Device programing and SMART pass algorithm activation in subcutaneous implantable defibrillator patients: Data from a remote monitoring database

Saverio Iacopino, Ezio Santobuono, Claudia Amellone, Antonio Rapacciuolo, Carlo Lavalle, Carmelo La Greca, Luca Santini, Matteo Bertini, Giovanni Statuto, Mariolina Lovecchio, Sergio Valsecchi, Vincenzo Tavoletta
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Abstract

BackgroundThe 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.PurposeWe assessed device programing during follow‐up and the rate of detected arrhythmias in consecutive S‐ICD recipients.MethodsWe 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.ResultsAt 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)).ConclusionsCenters 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.
皮下植入式除颤器患者的设备编程和 SMART 通行证算法激活:来自远程监控数据库的数据
背景在临床实践中,对皮下植入式心律转复除颤器(S-ICD)的编程研究很少,因为SMART Pass滤波器的激活状态旨在减少不适当的电击。结果在最近一次远程数据传输时,中位条件区截断值设定为210 bpm(第25-75百分位数:200-220),冲击区截断值为250 bpm(第25-75百分位数:240-250),586名(87%)患者启用了SMART Pass。随访期间,118 名(18%)患者报告了 194 次自动停用事件。129名(19%)患者接受了电击,136名(20%)患者出现了未治疗的心律失常。启用 SMART Pass 后,电击率为-0.12/患者年(95% CI:0.10-0.14)对 0.20(95% CI:0.15-0.26)(p = .002),未治疗心律失常率为-0.12/患者年(95% CI:0.11-0.14)对 0.23(95% CI:0.18-0.30)(p = .001)。增强型 SMART Pass 版本与较低的停用率相关-0.04/患者年(95% CI:0.02-0.05)对 0.14(95% CI:0.12-0.16)(p = .001),并与治疗和未治疗心律失常的减少相关(发病率比:0.40(95% CI:0.14)对 0.23(95% CI:0.18-0.30))(p = .001):结论中心倾向于将设备编程为检测心律失常的高心室率,以尽量减少不当电击的发生。SMART Pass 激活与较低的心律失常检测率和治疗率有关。增强型 SMART Pass 似乎与较低的停用率和进一步降低的心律失常治疗率有关。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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