The most reliable detection of atrial fibrillation (AF) during blood pressure measurements at home.
Atrial fibrillation (AF) causes high risk of stroke [1]. Approximately 40% of AF patients have no symptoms [2] so that many of them are diagnosed by coincidence when hospitalized for other reasons [3], including stroke [4, 5].
Who is affected?
AF is the most common sustained cardiac arrhythmia occurring in 5% of the population of 65 years and older and in 14% older than 85 years. AF leads to a 5-fold higher risk of stroke and is responsible for 20% of all strokes. Many people have no symptoms from AF and therefore remain undiagnosed. Early detection of AF followed by adequate treatment can reduce the risk of a stroke by 68%. [6-8]
What is Atrial Fibrillation (AF)?
In the case of AF, the heart chambers beat chaotically and irregularly. This can cause blood to accumulate in the atria of the heart, clump together, and form blood clots. These blood clots can then migrate through the bloodstream to the brain, where they block the blood vessels and this causes a stroke. The dangerous part of AF is, that about 70% of the AF episodes are asymptomatic and remain undiagnosed. In addition, in the beginning, AF generally appears only irregularly and can, therefore, be overlooked even during sporadic doctor's visits. Following risk factors can additionally increase the risk of having AF: age, hypertension, diabetes, obesity, cardiovascular diseases, stress, smoking and alcohol.
How Microlife’s patented AFIBsens technology works
Microlife blood pressure monitors with implemented AFIBsens™ technology, allow patients to be screened for AF during blood pressure measurements at home, using a sophisticated algorithm. If AF is detected during blood pressure measurements, the AFIB symbol is displayed. Microlife AFIBsens™ does not make a diagnosis, but provides important information for your doctor, who can refer you for a 12-lead ECG to confirm the presence of AF.
A systematic review of all clinical evidence to the Microlife AFIBsens™ detector [9] showed that the highest sensitivity value (97%) is obtained when separate, sequential heart rhythm analyses were performed, with two or three readings being AF positive. The highest specificity value (97%) is obtained when all three heart rhythm analyses being positive for AF. For this reason the Microlife blood pressure monitors with AFIBsens™ technology automatically carries out three heart rhythm analysis when screening for atrial fibrillation.
Microlife AFIBsens™ technology is implemented on Microlife blood pressure monitors in conjunction with the Microlife Average Mode (MAM) technology. Three analyses of heart rhythm are conducted in conjunction with the triplicate blood pressure measurements of MAM, and the AF screening result is provided together with the average blood pressure reading of MAM.
AFIBsens™ Advanced is the latest evolution of Microlife AFIBsens™ technology, to make AF screening at home more faster and more user friendly. Microlife blood pressure monitors with AFIBsens™ Advanced feature conducts three heart rhythm analyses for AF detection, whether using MAM’s triplicate measurement or the normal single measurement for blood pressure reading, to ensure the benefit of AF screening is always available at home.
Microlife AFIBsens: tested and clinically proven for detecting atrial fibrillation
Microlife AFIBsens detects AF with high accuracy (sensitivity 98%, specificity 92%) as demonstrated in multiple comparative studies with ECG. It can be used as a reliable screening test for early diagnosis.
Patients (n)
|
Setting
|
Average
age (y)
|
AF
n (%) |
Non-AF
arrhythmia (n) |
Sinus
(n)
|
Sensitivity
(%) |
Specificity
(%) |
|
Wiesel 2004 [10]
|
450
|
Hospital
|
69
|
53 (12)
|
1
|
396
|
100
|
92
|
Stergiou 2009 [11]
|
73
|
Hospital
|
71
|
27 (37)
|
23
|
23
|
100
|
89
|
Wiesel 2009 [12]
|
405
|
Hospital
|
73
|
93 (23)
|
64
|
248
|
97
|
89
|
Wiesel 2013
(Tripps) [13]
|
139
|
Home
|
67
|
14 (10)
|
n. s.
|
125
|
99*
|
93*
|
Oxford trial 2014 [14]
|
999
|
Primary care
practice
|
80
|
79 (8)
|
n. s.
|
920
|
95
|
90
|
Wiesel 2014 [15]
|
183
|
Hospital
|
74
|
30 (15)
|
n. s.
|
153
|
100
|
92
|
Gandolfo 2015 [16]
|
207
|
Hospital (stroke
patients)
|
78
|
38 (18.4)
|
n. s.
|
169
|
90
|
99
|
Chan 2017 [17]
|
2052
|
Primary care
|
68
|
24 (1.2)
|
156
|
1872
|
83
|
99
|
Chan 2017 [18]
|
5969
|
Primary care
|
67
|
72 (1.2)
|
430
|
5467
|
81
|
99
|
All studies were compared against 12-lead ECG unless otherwise indicated; n.s. indicates not specified; *compared against electrocardiographic diagram
Irregular heartbeat feature – what is the difference with AFIBsens technology?
“The main purpose of the IHB detector, therefore, is not to diagnose arrhythmias but rather to serve as a warning message indicating that the BP reading may not be accurate because of the presence of arrhythmia [9, 19]“
The majority of the available blood pressure devices allow blood pressure measurements to be applied simultaneously to irregular heartbeats and arrhythmias. However, this does not distinguish between the different types of arrhythmias. If the IHB / IHD symbol appears in the display, non-hazardous arrhythmias such as sinus arrhythmia, premature atrial contractions (PAC) or bradycardia are also included. This can lead to patient insecurity.
Microlife AFIBsens is the world's only, medically proven technology for blood pressure devices that only detects dangerous atrial fibrillation. The high degree of accuracy has been proven several times in clinical trials and has been recommended by international specialists and physicians.
Microlife AFIBsens in primary care
#1 Atrial fibrillation detection recommended by doctors [20]
The AF detection system has convincingly proven its accuracy and showed that it leads to increased detection of new patients with AF when used in general clinical practice.
Recommended by NICE (UK)
The National Institute for Health and Care Excellence (NICE) officially recommends using the WatchBP Home A during routine blood pressure measurement for all general practitioners in the United Kingdom. [20]
Oxford trial 2013
The University of Oxford in the UK, known as one of the best medical universities in the world, has performed a randomized clinical trial among 1,000 GP patients to reveal the best method for AF screening in primary care. This study showed that using the Microlife WatchBP Home A is the best method and is recommended for AF screening in primary care practice and for patients at home.
“Conclusions: WatchBP performs better as a triage test for identifying AF in primary care than the single-lead ECG monitors as it does not require expertise for interpretation and its diagnostic performance is comparable to single-lead ECG analysis by cardiologists. It could be used opportunistically to screen elderly patients for undiagnosed AF at regular intervals and/or during BP measurement. [14]”
* Microlife home blood pressure monitors with Microlife AFIBsens technology are not available in USA