Department of Cardiology, Tel Aviv Medical Center, 6 Weizmann Street, Tel Aviv, Tel-Aviv University, Tel Aviv 69978, Israel.
Donisi Health, Formerly Contin Use Biometrics Ltd., Tel Aviv 69978, Israel.
Biosensors (Basel). 2022 Oct 6;12(10):833. doi: 10.3390/bios12100833.
The cost of heart failure hospitalizations in the US alone is over USD 10 billion per year. Over 4 million Americans are hospitalized every year due to heart failure (HF), with a median length of stay of 4 days and an in-hospital mortality rate that exceeds 5%. Hospitalizations of patients with HF can be prevented by early detection of lung congestion. Our study assessed a new contact-free optical medical device used for the early detection of lung congestion.
The Gili system is an FDA-cleared device used for measuring chest motion vibration data. Lung congestion in the study was assessed clinically and verified via two cardiologists. An algorithm was developed using machine learning techniques, and cross-validation of the findings was performed to estimate the accuracy of the algorithm.
A total of 227 patients were recruited (101 cases vs. 126 controls). The sensitivity and specificity for the device in our study were 0.91 (95% CI: 0.86-0.93) and 0.91 (95% CI: 0.87-0.94), respectively. In all instances, the observed estimates of PPVs and NPVs were at least 0.82 and 0.90, respectively. The accuracy of the algorithm was not affected by different covariates (including respiratory or valvular conditions).
This study demonstrates the efficacy of a contact-free optical device for detecting lung congestion. Further validation of the study results across a larger and precise scale is warranted.
仅在美国，心力衰竭住院治疗的费用每年就超过 100 亿美元。每年有超过 400 万美国人因心力衰竭（HF）住院，平均住院时间为 4 天，住院死亡率超过 5%。通过早期发现肺充血，可以预防 HF 患者的住院。我们的研究评估了一种用于早期检测肺充血的新型非接触式光学医疗设备。
Gili 系统是一种经过 FDA 批准的用于测量胸部运动振动数据的设备。研究中的肺充血通过两位心脏病专家进行临床评估和验证。使用机器学习技术开发了一种算法，并对该算法的发现进行了交叉验证，以估计算法的准确性。
共招募了 227 名患者（101 例病例与 126 例对照）。该设备在我们研究中的灵敏度和特异性分别为 0.91（95%CI：0.86-0.93）和 0.91（95%CI：0.87-0.94）。在所有情况下，观察到的阳性预测值和阴性预测值均至少为 0.82 和 0.90。算法的准确性不受不同协变量（包括呼吸或瓣膜状况）的影响。
这项研究证明了一种非接触式光学设备检测肺充血的有效性。需要在更大和更精确的范围内进一步验证研究结果。
