Brinda AnneMarie K, Goudman Lisa, Moens Maarten, Hincapie Juan, Dinsmoor David A, Litvak Leonid M, Straka Małgorzata
Medtronic, Minneapolis, MN, United States.
STIMULUS Research Group, Vrije Universiteit Brussel, Brussels, Belgium.
Front Physiol. 2024 Aug 12;15:1342983. doi: 10.3389/fphys.2024.1342983. eCollection 2024.
In the search for objective measures of therapeutic outcomes for patients with spinal cord stimulation (SCS) devices, various metrics of cardiac performance have been linked to pain as well as overall health. To track such measures at home, recent studies have incorporated wearables to monitor cardiac activity over months or years. The drawbacks to wearables, such as patient compliance, would be obviated by on-device sensing that incorporates the SCS lead. This study sought to evaluate the feasibility of using SCS leads to record cardiac electrograms. The quality of signals sensed by externalized, percutaneous leads in the thoracic spine of 10 subjects at the end of their SCS trial were characterized across various electrode configurations and postures by detecting R-peaks and calculating signal-to-noise ratio (SNR). In a subset of 5 subjects, cardiac metrics were then compared to those measured simultaneously with a wearable. The average signal quality was acceptable for R-peak detection (i.e., SNR > 5) for all configurations and positions across all 10 subjects, with higher signal quality achieved when recording in resting positions. Notably, the spinal lead recordings enabled more reliable beat detection compared to the wearable ( = 29 recording pairs; < 0.001). When excluding wearable recordings with over 35% missed beats, the inter-beat intervals across devices were highly correlated ( = 22 recording pairs; Pearson correlation: R = 0.99, < 0.001). Further comparisons in these aligned wearable and corresponding spinal-lead recordings revealed significant differences in the frequency domain metrics (i.e., absolute and normalized high and low frequency HRV power, < 0.05), but not in time domain HRV parameters. The ability of an implanted SCS system to record electrocardiograms, as demonstrated here, could provide the basis of automated SCS therapy by tracking potential biomarkers of the patient's overall health state without the need for additional external devices.
在寻找脊髓刺激（SCS）设备患者治疗效果的客观指标时，各种心脏性能指标已与疼痛以及整体健康状况相关联。为了在家中跟踪这些指标，最近的研究采用了可穿戴设备来监测数月或数年的心脏活动。可穿戴设备的缺点，如患者依从性问题，可通过结合SCS导线的设备内传感来消除。本研究旨在评估使用SCS导线记录心脏电图的可行性。通过检测R波峰并计算信噪比（SNR），对10名受试者在SCS试验结束时胸椎外置经皮导线所感测信号的质量，在各种电极配置和姿势下进行了表征。在5名受试者的子集中，然后将心脏指标与同时使用可穿戴设备测量的指标进行比较。对于所有10名受试者的所有配置和位置，R波峰检测的平均信号质量是可接受的（即SNR>5），在静息位置记录时信号质量更高。值得注意的是，与可穿戴设备相比，脊髓导线记录能够实现更可靠的心跳检测（ = 29对记录； < 0.001）。当排除漏搏超过35%的可穿戴设备记录时，各设备间的心搏间期高度相关（ = 22对记录；Pearson相关性：R = 0.99， < 0.001）。在这些对齐的可穿戴设备和相应的脊髓导线记录中的进一步比较显示，频域指标（即绝对和归一化的高频和低频心率变异性功率， < 0.05）存在显著差异，但时域心率变异性参数无显著差异。如本文所示，植入式SCS系统记录心电图的能力可为自动SCS治疗提供基础，通过跟踪患者整体健康状态的潜在生物标志物，而无需额外的外部设备。
