Artificial intelligence-enabled single-lead ECG for non-invasive hyperkalemia detection: development, multicenter validation, and proof-of-concept deployment

TL;DR

This study developed and validated Pocket-K, an AI-enabled single-lead ECG system for non-invasive hyperkalemia detection, demonstrating high accuracy across multiple centers and enabling real-time handheld deployment.

Contribution

The paper introduces Pocket-K, a novel AI-ECG system for hyperkalemia screening, validated across multicenter datasets, and demonstrates its potential for real-time, non-invasive monitoring.

Findings

AUROC of 0.936 in internal testing

AUROC of 0.858 in temporal validation

AUROC of 0.808 in external validation

Abstract

Hyperkalemia is a life-threatening electrolyte disorder that is common in patients with chronic kidney disease and heart failure, yet frequent monitoring remains difficult outside hospital settings. We developed and validated Pocket-K, a single-lead AI-ECG system initialized from the ECGFounder foundation model for non-invasive hyperkalemia screening and handheld deployment. In this multicentre observational study using routinely collected clinical ECG and laboratory data, 34,439 patients contributed 62,290 ECG--potassium pairs. Lead I data were used to fine-tune the model. Data from Peking University People's Hospital were divided into development and temporal validation sets, and data from The Second Hospital of Tianjin Medical University served as an independent external validation set. Hyperkalemia was defined as venous serum potassium > 5.5 mmol/L. Pocket-K achieved AUROCs of 0.936 in internal testing, 0.858 in temporal validation, and 0.808 in external validation. For KDIGO-defined moderate-to-severe hyperkalemia (serum potassium >= 6.0 mmol/L), AUROCs increased to 0.940 and 0.861 in the temporal and external sets, respectively. External negative predictive value exceeded 99.3%. Model-predicted high risk below the hyperkalemia threshold was more common in patients with chronic kidney disease and heart failure. A handheld prototype enabled near-real-time inference, supporting future prospective evaluation in native handheld and wearable settings.