Development and Internal Validation of an AI-Enabled Cuff-less, Non-invasive Continuous Blood Pressure Monitor Across All Classes of Hypertension.

IF 2.4 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Journal of Cardiovascular Translational Research Pub Date : 2025-01-13 DOI:10.1007/s12265-024-10589-5

Francisco Lopez-Jimenez, Abhishek Deshmukh, John Bisognano, John Boehmer, Mouli Ramasamy, Prashanth Shyam Kumar, Suraj Kapa, Venk Varadan, Vijay Varadan, Marat Fudim

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Abstract

Background: Non-invasive, continuous blood pressure monitoring technologies require additional validation beyond standard cuff-based methods. This study evaluates a non-invasive, multiparametric wearable cuffless blood pressure (BP) diagnostic monitor across all hypertension classes with diverse subjects.

Methods: A prospective, multicenter study assessed Nanowear's SimpleSense-BP performance, including induced and natural BP changes, significant BP variations (Systolic BP (SBP) ≥ ± 15 mm Hg and Diastolic BP (DBP) ≥ ± 10 mm Hg), and reference input value validity over 4 weeks.

Results: 303 subjects (18-83 yrs; 50.16% Female) participated in algorithmic development and validation (Normal - 35%, Prehypertensive - 24%, Stage 1 - 24%, Stage 2 - 17%). 54 subjects were tested for induced change performance, 149 exhibited significant changes, and 91 validated reference value duration.

Conclusions: The study clinically validated a continuous, AI-based BP diagnostic monitor using non-invasive wearable data. Further testing on diverse populations and external validation are recommended. The protocol was inspired by ISO 81060-2 and IEEE 1708:2019 standards.

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开发并在内部验证人工智能无袖带无创连续血压监测仪，适用于所有类型的高血压。

背景：无创、连续的血压监测技术需要额外的验证，而不是标准的基于袖带的方法。本研究评估了一种无创、多参数可穿戴式无袖带血压（BP）诊断监测仪，适用于所有高血压类别和不同受试者。方法：一项前瞻性、多中心研究评估了Nanowear的SimpleSense-BP性能，包括诱导的和自然的血压变化、显著的血压变化(收缩压（SBP)≥±15mm Hg和舒张压(DBP)≥±10mm Hg），以及4周内参考输入值的有效性。结果：303名受试者(18-83岁；50.16%女性)参与了算法的开发和验证（正常- 35%，高血压前期- 24%，1期- 24%，2期- 17%）。54名受试者进行诱导变化表现测试，149名受试者表现为显著变化，91名受试者进行参考值持续时间验证。结论：该研究临床验证了一种使用无创可穿戴数据的连续的、基于人工智能的血压诊断监测仪。建议对不同人群进行进一步测试并进行外部验证。该协议的灵感来自ISO 81060-2和IEEE 1708:2019标准。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Cardiovascular Translational Research CARDIAC & CARDIOVASCULAR SYSTEMS-MEDICINE, RESEARCH & EXPERIMENTAL

CiteScore

6.10

自引率

2.90%

发文量

148

审稿时长

6-12 weeks

期刊介绍： Journal of Cardiovascular Translational Research (JCTR) is a premier journal in cardiovascular translational research. JCTR is the journal of choice for authors seeking the broadest audience for emerging technologies, therapies and diagnostics, pre-clinical research, and first-in-man clinical trials. JCTR''s intent is to provide a forum for critical evaluation of the novel cardiovascular science, to showcase important and clinically relevant aspects of the new research, as well as to discuss the impediments that may need to be overcome during the translation to patient care.