Department of Cardiology, Fondazione Cardiocentro Ticino, Via Tesserete 48, 6900, Lugano, Switzerland.
Cantonal Hospital of Fribourg (HFR), Fribourg, Switzerland.
BMC Cardiovasc Disord. 2019 Jun 17;19(1):146. doi: 10.1186/s12872-019-1121-4.
Little is known about the ICD performance using enhanced detection algorithms in unselected, non-trial patients. Performance of recent generation ICD equipped with SmartShock™ technology (SST) for detection and conversion of ventricular tachyarrhythmias (VTA) was investigated.
4P was a prospective, multicenter, observational study conducted in 10 Swiss implanting centers. Patients with a Class I indication according to international guidelines were included and received an ICD with SST. ICD discrimination capability was assessed by evaluating SST performance; therapy efficacy was assessed by rate of VTA conversions by ATP and by rescue shocks.
Overall, 196 patients were included in the analysis with a mean duration of follow-up of 27.7 months (452 patient-years of observation). Patient-specific rather than recommended programming was preferred. Device-detected episodes were frequent (5147 episodes in 146 patients, 74.5%). In 44 patients (22.4%), 1274 episodes were categorized as VTA; only 215 episodes were symptomatic. ATP was the first-line therapy and highly effective (99.9% success rate at the episode level, 100.0% at the patient level). Rescue shocks were rare (66 episodes in 28 patients); 7 shocks in 5 patients (2.6%) were inappropriate. Death and hospitalization rates were low.
In a cohort of non-trial, unselected ICD patients, VTA episodes were frequent. The 4P results confirm the robustness of VTA detection by SST and the effectiveness of ATP treatment, hence limiting overall ICD shock burden.
在未经选择的非试验患者中，使用增强检测算法的 ICD 性能知之甚少。研究了配备 SmartShock™ 技术 (SST) 的新一代 ICD 检测和转换室性心动过速 (VTA) 的性能。
4P 是一项前瞻性、多中心、观察性研究，在瑞士的 10 个植入中心进行。根据国际指南，具有 I 类适应证的患者被纳入并接受配备 SST 的 ICD。通过评估 SST 性能来评估 ICD 鉴别能力；通过 ATP 转换的 VTA 率和挽救性电击的疗效来评估治疗效果。
共有 196 名患者纳入分析，平均随访时间为 27.7 个月（观察 452 人年）。首选患者特异性而非推荐的编程。设备检测到的发作很频繁（146 名患者中有 5147 个发作，74.5%）。在 44 名患者（22.4%）中，有 1274 个发作被归类为 VTA；只有 215 个发作是有症状的。ATP 是一线治疗方法，非常有效（发作水平成功率为 99.9%，患者水平成功率为 100.0%）。挽救性电击很少见（28 名患者中有 66 个发作）；5 名患者中有 7 个电击（2.6%）是不适当的。死亡率和住院率很低。
在非试验、未经选择的 ICD 患者队列中，VTA 发作很频繁。4P 结果证实了 SST 对 VTA 检测的稳健性和 ATP 治疗的有效性，从而限制了整体 ICD 电击负担。
