What is the clinical evidence from this study?

Study design: Observational. Population: Cardiac rehabilitation (n=54). Intervention: Aktiia cuffless continual blood pressure monitor vs. Standard 24-h ambulatory BP monitor (ABPM). Primary outcome: 24-h systolic blood pressure (MD 2.6 mmHg, 95% CI -0.2 to 5.4, p=0.06).

February 7, 2025Open Access

Evaluation of Aktiia cuffless blood pressure monitor across 24-h, daytime, and night-time measurements versus ambulatory monitoring: a prospective, single-centre observational study

TATiago P. AlmeidaKarlsruhe Institute of Technology DPDavid PerruchoudAktive Arc (Switzerland)JAJérémy AlexandreInserm

Key Result

The Aktiia cuffless blood pressure monitor yielded 24-h systolic blood pressure measurements consistent with standard ABPM (mean difference 2.6 mmHg; 95% CI -0.2 to 5.4; P=0.06).

Study Design

Type

Observational (n=54)

Multicenter

Structured PICO

Does a cuffless, continual blood pressure monitor provide measurements consistent with a standard 24-h ambulatory blood pressure monitor in patients undergoing cardiac rehabilitation?

Population

54 patients undergoing a 12-week cardiac rehabilitation program evaluated for continual blood pressure monitoring.

Exposure

Cuffless, continual blood pressure monitor (Aktiia monitor) using a 7-day average

Comparator

Standard 24-h ambulatory blood pressure monitor (ABPM; Dyasis 3) using a 1-day average

Outcome

Comparison of 24-h, daytime (9 a.m.-9 p.m.), and night-time (11 p.m.-7 a.m.) systolic and diastolic blood pressuresurrogate

The Aktiia cuffless blood pressure monitor provides 24-hour and daytime measurements consistent with standard ambulatory monitoring, though systematic differences exist during night-time readings.

Main Result

Mean Difference: 2.6 (95% CI -0.2–5.4)

p-value: p=0.06

Limitations

Systematic differences during night-time readings

Abstract

OBJECTIVES: Cuffless blood pressure (BP) monitors represent an innovative approach to BP assessment, overcoming the traditional episodic nature of readings obtained from cuff-based, oscillometric modalities. Nonetheless, the comparison of these cuffless devices against their cuff-based counterparts remain debated. METHODS: This study evaluated BP readings from a cuffless, continual BP monitor (Aktiia monitor, Neuchâtel, Switzerland) and a standard 24-h ambulatory BP monitor (ABPM; Dyasis 3, Novacor, Paris, France) in 54 patients undergoing a 12-week cardiac rehabilitation program in Neuchâtel, Switzerland. Comparisons encompassed 24-h, daytime (9 a.m.-9 p.m.), and night-time (11 p.m.-7 a.m.) systolic and diastolic BP (SBP, DBP) using a 7-day average from Aktiia overlapping a 1-day average from ABPM. Nocturnal dip analysis was performed with 1-day average from Aktiia coinciding with ABPM measurements. RESULTS: No significant differences emerged between the Aktiia and ABPM monitors for 24-h and daytime SBP (24-h: 2.6 ± 12.3 -0.2, 5.4 mmHg, r = 0.57, P = 0.06; daytime: 1.2 ± 12.4 -1.6, 4.0 mmHg, r = 0.60, P = 0.38). Night-time SBP showed more evident differences (12.5 ± 14.4 9.3, 15.8 mmHg, r = 0.39, P < 0.001). DBP were within clinical range across 24-h and daytime (24-h: -2.9 ± 7.9 -4.7, -1.1 mmHg, r = 0.63, P = 0.002; daytime: -3.1 ± 8.2 -5.0, -1.3 mmHg, r = 0.64, P = 0.001), and showed significant differences for night-time (4.1 ± 8.5 2.2, 6.0 mmHg, r = 0.57, P < 0.001). The concordance rate with ABPM's nocturnal dip was 79% for 1-day average from Aktiia. CONCLUSIONS: These results demonstrate that the Aktiia monitor yields BP measurements consistent with an ABPM monitor despite some systematic differences during night-time readings. The Aktiia monitor holds potential for future use in continual BP monitoring. CLINICAL TRIAL REGISTRATION: NCT04548986. URL: https://clinicaltrials.gov/study/NCT04548986?tab=results.

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