Subcutaneous Implantable Defibrillator programming: an analysis of Italian clinical practice and its evolution

Abstract

Abstract Background The UNTOUCHED study (designed in 2017 and published in 2021) demonstrated high success rate for termination of ventricular arrhythmias, and very low inappropriate shock rate in subcutaneous implantable cardioverter-defibrillator (S-ICD) recipients. The prescribed device programming included a conditional zone between 200 and 250 beats per minute (bpm) with discrimination algorithms employed to avoid delivering inappropriate shocks in this range, and a shock zone based on the rate alone for arrhythmias >250 bpm. Whether these results influenced clinical practice is unknown. Methods We assessed the programming at implantation and changes in programmed parameters at follow-up (≥1 year) in a cohort of S-ICD recipients enrolled in the Rhythm Detect registry at 56 centers. Results From 2013 to 2021, 1521 consecutive patients (aged 49±15 years; 79% male, 52% dilated cardiomyopathy, 31% arrhythmic syndromes, 16% hypertrophic cardiomyopathy) were analyzed. At implantation, the programmed sensing vector was the Primary in 59% of patients, the Secondary in 35%, the Alternate in 6%. At follow-up, the sensed vector was changed in 13% of patients. The programmed conditional zone cutoff was set to 200 [200–220] bpm (median [25–75 percentile]), and the shock zone cutoff to 230 [210–250] bpm. At follow-up, the conditional zone cutoff was reprogrammed in 13% of patients, but the median value in the overall population did not change (200 [200–220] bpm; p>0.05). The shock zone cutoff was reprogrammed in 43% of cases, and the overall median value was 250 [230–250] bpm (p<0.001 versus implantation). Sorting patients by implantation date, we observed that in the first 764 patients (implanted ≤2017) the shock zone cutoff was set to 210 [210–230] bpm at implantation and to 240 [230–250] bpm at follow-up (reprogrammed in 66% of cases). While in patients implanted >2017, it was already set to 250 [230–250] bpm at implantation and to 250 [240–250] bpm at follow-up (reprogrammed in 20% of cases, p<0.001 versus ≤2017). Conclusions S-ICD programming parameters are rarely changed during follow-up (approximately 13% of patients). The only exception in clinical practice was the shock zone cutoff. Centers have begun to program high cutoffs in recent years. This happened at the time of implantation for new S-ICD recipients and at follow-up for pre-existing implants. This behavior is consistent with a substantial adoption of published trial findings and could contribute to reduce the incidence of inappropriate shocks in clinical practice. Funding Acknowledgement Type of funding sources: None.