Clinical Validation of Photoplethysmography‐Based Finger Cuffless Blood Pressure Monitoring Following European Society of Hypertension Recommendations

BACKGROUND: Cuffless blood pressure (BP) monitoring remains challenging for clinical hypertension management. Although photoplethysmography offers promising solutions for cuffless BP measurement, its clinical validation is limited. This study evaluated the accuracy and clinical utility of photoplethysmography-based finger cuffless BP monitoring following European Society of Hypertension recommendations. METHODS: The 2-phase study enrolled 1173 participants. In phase 1 (n=768), a novel photoplethysmography-based finger cuffless BP monitor was validated against invasive BP, office BP, and 24-hour ambulatory BP monitoring across 7 European Society of Hypertension-recommended scenarios. In phase 2 (n=405 hypertensive patients), the clinical utility of photoplethysmography- versus ambulatory BP monitoring-derived mean systolic BP (SBP), SBP time-in-target range, and variability was assessed by examining their associations with hypertension-mediated organ damage and cardiovascular complications, including arterial stiffness, endothelial dysfunction, coronary heart disease, and stroke. RESULTS: The photoplethysmography-based finger cuffless BP monitor fulfilled all validation criteria, with mean differences ≤5 mm Hg and standard deviations ≤8 mm Hg of both systolic and diastolic BP across 7 scenarios, including invasive, static, awake/asleep, device position, treatment, exercise, and recalibration test. Both ambulatory BP monitoring-derived time-in-target range and photoplethysmography-derived mean SBP and time-in-target range were significantly associated with endothelial injury and arterial stiffness. Notably, photoplethysmography-derived mean SBP and time-in-target range, but not ambulatory BP monitoring-derived metrics, showed a significant association with coronary artery disease. Furthermore, photoplethysmography-derived SBP variability was significantly and positively associated with endothelial injury. CONCLUSIONS: Our data demonstrated that the novel photoplethysmography-based finger cuffless BP monitor reached the criteria of clinical application following European Society of Hypertension recommendations and provided additional clinical implications for the evaluation of hypertension-mediated organ damage and cardiovascular complications.