Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands.
Department of Clinical and Experimental Cardiology, Heart Center, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Heart Rhythm. 2018 Oct;15(10):1515-1522. doi: 10.1016/j.hrthm.2018.05.011. Epub 2018 Jun 8.
Most inappropriate shocks from the subcutaneous implantable cardioverter-defibrillator (S-ICD) are caused by cardiac oversensing. A novel sensing methodology, SMART Pass (SP; Boston Scientific Corporation, Natick, MA), aims to reduce cardiac oversensing.
The purpose of this study was to evaluate the effect of SP on shocks in ambulatory patients with S-ICD.
Patients implanted in 2015-2016 and enrolled in a remote patient monitoring system were included and followed for 1 year. Shocks were adjudicated by 3 independent blinded reviewers as appropriate or inappropriate. Shock incidence was calculated for patients with SP programmed enabled or disabled at implantation, censoring patients when SP programming changed or at the last transmission. The SP setting (enabled vs disabled) was modeled as a time-dependent Cox regression variable.
The cohort consisted of 1984 patients, and a total of 880 shocks were adjudicated. At implantation, SP was enabled in 655 patients (33%) and disabled in 1329 patients (67%). SP reduced the risk for the first inappropriate shock by 50% (P < .001) and the risk for all inappropriate shocks by 68% (P < .001) in multivariate analysis adjusted for age and device programming. The incidence of inappropriate shocks was 4.3% in the SP enabled arm vs 9.7% in the SP disabled arm. The incidence of appropriate shocks was similar (5.2% vs 6.6%; P = .18) along with the time to treat the first appropriate shock (17.4 seconds vs 16.7 seconds; P = .92) for SP enabled vs disabled, respectively.
This prospective blinded evaluation of the SP filter demonstrates that enabling the SP filter results in a significant reduction of inappropriate shocks by the S-ICD without a negative effect on appropriate shocks.
皮下植入式心律转复除颤器（S-ICD）最不合适的电击是由心脏过度感知引起的。一种新的感知方法，即 SMART Pass（SP；波士顿科学公司，马萨诸塞州纳提克），旨在减少心脏过度感知。
本研究旨在评估 SP 对 S-ICD 门诊患者电击的影响。
纳入 2015-2016 年植入并纳入远程患者监测系统的患者，并随访 1 年。电击由 3 位独立的盲法审查者进行判断，分为适当或不适当。在植入时启用或禁用 SP 编程的患者中计算电击发生率，当 SP 编程改变或最后一次传输时，对患者进行删失。SP 设置（启用与禁用）被建模为一个时间依赖性 Cox 回归变量。
该队列包括 1984 例患者，共判定 880 次电击。在植入时，655 例患者（33%）启用 SP，1329 例患者（67%）禁用 SP。多变量分析调整年龄和设备编程后，SP 可将首次不适当电击的风险降低 50%（P <.001），所有不适当电击的风险降低 68%（P <.001）。启用 SP 组的不适当电击发生率为 4.3%，禁用 SP 组为 9.7%。适当电击的发生率相似（5.2%对 6.6%；P =.18），启用 SP 组与禁用 SP 组首次适当电击的治疗时间也相似（17.4 秒对 16.7 秒；P =.92）。
本前瞻性、盲法评估 SP 滤波器的研究表明，启用 SP 滤波器可显著减少 S-ICD 的不适当电击，而对适当电击无负面影响。
