Confirm Rx™ SharpSense AF 检测算法的 "真实世界 "性能：英国 Confirm Rx 研究

IF 2.2 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Journal of Arrhythmia Pub Date : 2024-09-03 DOI:10.1002/joa3.13124

Andre Briosa e Gala MD, Michael T. B. Pope BM, BSc, Milena Leo MD, PhD, Alexander J. Sharp MBBS, BSc, Abhirup Banerjee PhD, Duncan Field MD, Honey Thomas MD, Richard Balasubramaniam Mb, ChB, PhD, Ross Hunter PhD, Roy S. Gardner MD, David Wilson DM, Mark M. Gallagher MD, Julian Ormerod PhD, John Paisey MD, Nick Curzen PhD, Timothy R. Betts MD

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引用次数: 0

摘要

导言：采用 SharpSense™ 技术的新型 Confirm Rx™ 植入式心脏监护仪 (ICM) 集成了新型 P 波鉴别器，旨在提高房颤检测能力。本研究旨在评估 Confirm Rx™ ICM 在检测不同持续时间的房颤发作方面的诊断性能。方法我们对英国九家医院连续植入 Confirm Rx™ ICM（v1.2 版）的患者进行了多中心回顾性分析，所有患者都有至少持续 6 分钟的房颤记录。心电图 (ECG) 由心脏病专家人工判定。为考虑审查者内部和审查者之间的差异，随机抽取 10% 的心电图进行额外审查。出现分歧时由第三位审查员解决。通过计算不同持续时间的房颤发作的总阳性预测值 (PPV) 和患者平均阳性预测值 (PPV)，确定诊断性能。假阳性 (FP) 检测的来源也进行了分类。结果共纳入 232 名患者的 16,230 张心电图。房颤发作持续时间的中位数为 14 分钟。随访期间 R 波振幅保持稳定（0.52 ± 0.27 mV [初始] vs. 0.54 ± 0.29 mV [随访结束]，p = .10）。总 PPV 和患者平均 PPV 分别为 75.0% 和 67.0%。心动过速时 FP 的主要来源是 T 波超感（54.2%），而非心动过速发作时主要是异位（71.2%）。房颤负荷精确度非常高（93.3%）。结论 Confirm Rx™ ICM 诊断所有房颤发作的准确率都不高（75%），房颤发作时间越长，准确率越高。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

“Real-world” performance of the Confirm Rx™ SharpSense AF detection algorithm: UK Confirm Rx study

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“Real-world” performance of the Confirm Rx™ SharpSense AF detection algorithm: UK Confirm Rx study

Introduction

The novel Confirm Rx™ implantable cardiac monitor (ICM) with SharpSense™ technology incorporates a new P-wave discriminator designed to improve AF detection. This study aimed to evaluate the diagnostic performance of the Confirm Rx™ ICM in detecting AF episodes of varying durations.

Methods

We conducted a multicenter retrospective analysis of consecutive patients implanted with a Confirm Rx™ ICM (v1.2) across nine UK hospitals, all with documented AF lasting at least 6 min. Electrocardiograms (ECGs) were manually adjudicated by cardiologists. To account for intra- and inter-reviewer variability, a random sample of 10% of ECGs underwent additional review. Disagreements were resolved by a third reviewer. Diagnostic performance was determined by calculating the gross and patient-averaged positive predictive value (PPV) for AF episodes of different duration. The source of false positive (FP) detection was also categorized.

Results

Overall, 16,230 individual ECGs from 232 patients were included. The median AF episode duration was 14 min. R-wave amplitude remained stable during follow-up (0.52 ± 0.27 mV [initial] vs. 0.54 ± 0.29 mV [end of follow-up], p = .10). The gross and patient-averaged PPV were 75.0% and 67.0%, respectively. Diagnostic performance (gross) increased with progressively longer AF episodes: 88.0% for ≥1 h, 97.3% for 6 h, and 100% for 24 h. The main source of FP during tachycardia was T-wave oversensing (54.2%), while in non-tachycardic episodes it was predominantly ectopy (71.2%). The AF burden precision was excellent (93.3%).