Background: The programing of subcutaneous implantable cardioverter-defibrillators (S-ICD) in clinical practice has been little studied, as the activation status of the SMART Pass filter, which was implemented to reduce inappropriate shocks. Purpose: We assessed device programing during follow-up and the rate of detected arrhythmias in consecutive S-ICD recipients. Methods: We analyzed data from 670 S-ICD patients followed on the remote network at 17 Italian centers for a median of 31 months (25th-75th percentile: 16-51). The enhanced SMART Pass version, introduced in October 2022, was expected to reduce the unintentional deactivation rate. Results: At the latest remote data transmission, the median conditional zone cut-off was set to 210 bpm (25th-75th percentile: 200-220), the shock zone cutoff was 250 bpm (25th-75th percentile: 240-250), and the SMART Pass was enabled in 586 (87%) patients. During follow-up, 194 automatic deactivation events were reported in 118 (18%) patients. Shocks were delivered in 129 (19%) patients, and untreated arrhythmias were recorded in 136 (20%) patients. The rate of shocks was lower when SMART Pass was enabled -0.12/patient-year (95% CI: 0.10-0.14) versus 0.20 (95% CI: 0.15-0.26) (p = .002), as it was the rate of untreated arrhythmias -0.12/patient-year (95% CI: 0.11-0.14) versus 0.23 (95% CI: 0.18-0.30) (p = .001). The enhanced SMART Pass version was associated with a lower rate of deactivations -0.04/patient-year (95% CI: 0.02-0.05) versus 0.14 (95% CI: 0.12-0.16) (p < .001), and with a reduction in treated and untreated arrhythmias (Incidence rate ratios: 0.40 (95% CI: 0.28-0.53) and 0.40 (95% CI: 0.30-0.55), respectively (p < .001)). Conclusions: Centers tend to program devices to detect high ventricular rates for arrhythmia detection, to minimize inappropriate shock occurrences. SMART Pass activation is associated with lower rates of detected and treated arrhythmias. The enhanced SMART Pass version seems associated with a lower deactivation rate and with a further decrease in treated arrhythmias.
Device programing and SMART pass algorithm activation in subcutaneous implantable defibrillator patients: Data from a remote monitoring database
Santobuono, Ezio;
2024-01-01
Abstract
Background: The programing of subcutaneous implantable cardioverter-defibrillators (S-ICD) in clinical practice has been little studied, as the activation status of the SMART Pass filter, which was implemented to reduce inappropriate shocks. Purpose: We assessed device programing during follow-up and the rate of detected arrhythmias in consecutive S-ICD recipients. Methods: We analyzed data from 670 S-ICD patients followed on the remote network at 17 Italian centers for a median of 31 months (25th-75th percentile: 16-51). The enhanced SMART Pass version, introduced in October 2022, was expected to reduce the unintentional deactivation rate. Results: At the latest remote data transmission, the median conditional zone cut-off was set to 210 bpm (25th-75th percentile: 200-220), the shock zone cutoff was 250 bpm (25th-75th percentile: 240-250), and the SMART Pass was enabled in 586 (87%) patients. During follow-up, 194 automatic deactivation events were reported in 118 (18%) patients. Shocks were delivered in 129 (19%) patients, and untreated arrhythmias were recorded in 136 (20%) patients. The rate of shocks was lower when SMART Pass was enabled -0.12/patient-year (95% CI: 0.10-0.14) versus 0.20 (95% CI: 0.15-0.26) (p = .002), as it was the rate of untreated arrhythmias -0.12/patient-year (95% CI: 0.11-0.14) versus 0.23 (95% CI: 0.18-0.30) (p = .001). The enhanced SMART Pass version was associated with a lower rate of deactivations -0.04/patient-year (95% CI: 0.02-0.05) versus 0.14 (95% CI: 0.12-0.16) (p < .001), and with a reduction in treated and untreated arrhythmias (Incidence rate ratios: 0.40 (95% CI: 0.28-0.53) and 0.40 (95% CI: 0.30-0.55), respectively (p < .001)). Conclusions: Centers tend to program devices to detect high ventricular rates for arrhythmia detection, to minimize inappropriate shock occurrences. SMART Pass activation is associated with lower rates of detected and treated arrhythmias. The enhanced SMART Pass version seems associated with a lower deactivation rate and with a further decrease in treated arrhythmias.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
