Corsano's CardioWatch 287-2 is a transformative solution for hypertension monitoring, highlighting its potential to replace traditional 24-hour ABPM. The discreet wristworn device offers continuous monitoring of vital parameters, including blood pressure, and features advanced customization, enabling tailored patient experiences and prompt identification of deviations. Findings from a clinical trial demonstrate its accuracy and reliability, correlating with invasive measurements. The device’s ability for homebased use, integrated data visualization, and timely intervention, positions it as a viable, less burdensome alternative, with implications for enhanced patient adherence and individualized healthcare.

The Corsano Cuffless Non-Invasive Blood Pressure algorithm was validated during MULTI-VITAL and RECAMO studies (Clinical- Trials.gov registered under NCT05566886 and NCT05899959) according to ESH Recommendations (based on ISO81060-2:2018 + Amd1:2020 & IEEE 1708+1708a standards).

Background

Cardiovascular diseases (CVD) stand out as a global health crisis, being the primary cause of death worldwide, accounting for 32% of all global fatalities 1]. Unfortunately, the number of individuals afflicted by CVD continues to rise annually [1]. Among the known risk factors for CVD, high blood pressure (BP), also known as hypertension, holds the strongest causal association and is prevalent across a large portion of the population [2]. Globally, an estimated 1.28 billion individuals suffer from hypertension, underscoring its widespread impact [1]. Research has shown that reducing BP through various interventions can significantly decrease the risk of CVD. Preventing age-related increases in BP, combined with the effective treatment of established hypertension, has the potential to reduce the burden of CVD on the population [2,3]. To achieve this, accurate monitoring and measurement of BP are essential and should be performed regularly [3,4].

 

Currently, BP measurements are typically taken during occasional visits to outpatient clinics. This sporadic approach may not capture the true variations in BP over time and can result in missing important risk factors for CVD, such as nighttime BP dips, hindering the optimal management of high BP [5]. Moreover, in-hospital measurements are cumbersome for healthcare personnel and can be influenced by factors such as isolated office hypertension and masked hypertension [6,7]. Finally, cuff-based BP measurement do not always correlate well with internal measurements in conditions like high BP or widespread vessel disease [8].

1 World Health Organization. Cardiovascular diseases http://www.who.int/news-room/factsheets/detail/cardiovascular-diseases-(cvds)
2 Fuchs FD, Whelton PK. High blood pressure and cardiovascular disease. Hypertension. 2020;75(2):285–92 doi: 10.1161/hypertensionaha.119.14240
3 Breaux-Shropshire T, Judd E, Vucovich L, Shropshire T, Singh S. Does home blood pressure monitoring improve patient outcomes? A systematic review comparing home and ambulatory blood pressure monitoring on blood pressure control and patient outcomes. Integrated Blood Pressure Control. 2015;43 doi: 10.2147/ibpc.s49205
4 Rahimi K, Bidel Z, Nazarzadeh M, Copland E, Canoy D, Ramakrishnan R, et al. Pharmacological blood pressure lowering for primary and secondary prevention of cardiovascular disease across different levels of blood pressure: An individual participant-level data meta-analysis. The
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5 Dennis Bloomfield, Alex Park. Nighttime blood pressure dip. World Journal of Cardiology doi: 10.4330/wjc.v7.i7.373
6. Muntner P, Shimbo D, Carey RM, Charleston JB, Gaillard T, Misra S, et al. Measurement of blood pressure in humans: A scientific statement from the American Heart Association. Hypertension. 2019;73(5) doi: 10.1161/hyp.0000000000000087
7 Papadogiannis DE, Protogerou AD. Blood pressure variability: A confounder and a cardiovascular risk factor. Hypertension Research. 2010;34(2):162–3 doi: 10.1038/hr.2010.223
8 Bui TV, Picone DS, Schultz MG, Armstrong MK, Peng X, Black JA, et al. Comparison between cuff-based and invasive systolic blood pressure amplification. Journal of Hypertension doi:10.1097/hjh.0000000000003228

Validation

Corsano's CardioWatch 287-2 Cuffless Non-Invasive Blood Pressure algorithm was evaluated in prospective single-centre investigations involving adult patients at Reinier de Graaf Gasthuis (Delft), a teaching hospital in The Netherlands. Results are meeting the ISO81060-2:2019 + A1:2020 and AAMI/ESH/ISO collaboration statement requirements:

Bland-Altman plots comparing the Corsano Cardio-Watch 287 Software derived BP and the invasive Fysicon reference BP pooled over All subjects. The solid line represents the bias and the dashed line represents the Limits of Agreement.

Dipping Patterns

The fall in pressure, called the “dip”, is defined as the difference between daytime mean systolic pressure and nighttime mean systolic pressure expressed as a percentage of the day value. Ten percent to 20% is considered normal. Dips less than 10%, referred to as blunted or absent, have been considered as predicting an adverse cardiovascular event [5].

NIBP under Exercise

The Corsano Cuffless Non-Invasive Blood Pressure algorithm was tested under High-Intensity Interval Training (HIIT) to evaluate the ability of the cuffless device to track physiological BP in-creases. Submaximal cycling, which has limited risks for subjects, was employed to induce substantial, shortterm but steady (for a couple of minutes) BP increases [14]
14 George S. Stergiou, et al. European Society of Hypertension recommendations for the validation of cuffless blood pressure measuring devices: European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability. Journal of Hypertension doi: 10.1097/HJH.0000000000003483

Advantages of the Corsano CardioWatch

Building on the empirical insights gained from the aforementioned studies, we now turn our focus to the multifarious advantages offered by the Corsano CardioWatch in facilitating the early detection and management of hypertension.