Screening Patients for Elevated Left Ventricular End-Diastolic Pressure Using a Novel Noninvasive Brachial Cuff-ECG System: A Multicenter Validation Study.

Document Type

Article

Publication Date

1-2026

Publication Title

Journal of the American Heart Association

Abstract

BACKGROUND: Measurement of left ventricular end-diastolic pressure (LVEDP) is an established diagnostic method to evaluate heart failure but requires an invasive procedure. A noninvasive technique for detecting elevated LVEDP would improve the diagnosis of heart failure. Herein, we present the results of a multicenter study to validate a noninvasive system to detect elevated LVEDP.

METHODS: The Vivio System includes a modified blood pressure cuff and single-lead ECG to capture brachial artery waveforms. A model was created to identify patients with elevated LVEDP (>18 mm Hg). For the invasive cohort, all patients were referred for coronary angiography and left heart catheterization for clinical indications. A group of 321 patients with no significant health problems were enrolled as a control cohort. Invasive LVEDP measurements were performed using Millar catheters. The training data set (n=262) contained 101 patients with LVEDP measurements (n=44 with LVEDP >18 mm Hg) and 161 controls. The validation data set (n=155) contained 75 patients with LVEDP measurements (n=40 with LVEDP >18 mm Hg) and 80 controls.

RESULTS: Leave-one-out cross-validation on the training data set yielded a sensitivity of 0.84 (95% CI, 0.70-0.93]) and a specificity of 0.84 (95% CI, 0.79-0.89). The validation data set showed a sensitivity of 0.80 (95% CI, 0.64-0.91) and a specificity of 0.83 (95% CI, 0.75-0.90).

CONCLUSIONS: The Vivio System can accurately detect elevated LVEDP and has the potential to significantly improve early detection of heart failure in the outpatient setting.

Volume

15

Issue

1

First Page

e040879

Last Page

e040879

DOI

10.1161/jaha.124.040879

ISSN

2047-9980

PubMed ID

41404757

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