The rising incidence of cardiovascular diseases (CVDs) is putting tremendous pressure on healthcare systems worldwide. Hospitals are struggling to answer the growing demands of an ageing population while managing limited budgets. Prevention, early diagnosis, selective treatments and length of hospitalisation all play an important role in cost management.
Developed by Advanced Bioelectric Corporation, AccuHeart™ is a novel dry electrode technology for long-term cardiac ambulatory monitoring. Due to the fact that it does not use gel or adhesives, AccuHeart™ frees patients from the skin irritations and other problems associated with current electrode technology. This improves patient compliance levels and their quality of life, while providing healthcare professionals with the electrocardiogram (ECG) data needed for proper diagnosis.
Cardiac Ambulatory Monitoring - A Growing Demand
According to a 2002 report by Frost and Sullivan entitled ÔÇ£US Cardiovascular Monitoring Equipment MarketsÔÇØ, hospitals and governments are embracing ambulatory monitoring as an acceptable and effective way of reducing the length of a patientÔÇÖs stay at hospital and even of preventing hospitalisation altogether. The ambulatory and tele-medical fields are by far the fastest growing markets for new monitoring technologies - in fact, current forecasts predict that these two sectors will grow by as much as 12% per annum over the next few years.
Current Monitors - A Review
The most common type of ambulatory monitoring is called Holter monitoring. This is a 24-48 hour continuous ECG ambulatory monitoring procedure that allows the recording of at least two channels. One advantage of Holter monitoring is that it will capture asymptomatic as well as symptomatic arrhythmias - the patient simply activates a button to mark the time of an event. Its major drawback is the short duration window, which is often inadequate to capture one or more arrhythmias for diagnosis.
Loop Event Recorders (LER)
Transtelephonic Electrocardiographic Monitors are used extensively in North America, but rather less in Europe. These monitors have a memory that is continuously looping. When a symptom occurs, the patient manually activates the recorder, which captures ECG data in the memory roughly one minute before and one minute after activation. The ECG data is then transmitted acoustically via the telephone line to a monitoring centre for review by specialists. In the US, the LER procedure is 30 days. The main advantage compared to a Holter is the increased yield for the detection of arrhythmias as shown in Figure 1. The main problem associated with the procedure is the lower level of compliance because of the skin problems, irritations and allergies, associated with the use of gel electrodes.
Insertable Loop Event Recorder (ILER)
Approximately five years ago, Medtronic introduced a new type of LER for the monitoring of patients suffering from syncope (fainting) of unknown origin. This LER is a small device that is surgically implanted under the skin of the patient.
In the US, there are more than three million emergency visits every year because of syncope. The occurrences are generally rare; it is not uncommon for people to experience this problem only once every two, three or four months, or even less frequently. Syncope is extremely debilitating as sufferers live in constant fear of the next fainting episode and the possibility that it may lead to serious injury or death. Their quality of life is drastically affected.
Due to the problems associated with gel electrodes over the long term, external LER (ELER) technology is not a viable option for syncope sufferers. On the other hand, since the patient can wear the insertable device over many months without experiencing serious skin problems, the diagnostic yield achieved with an ILER is high when compared with a current LER or Holter (see Figure 2). The major drawback with these ILERs is the cost, which is reported to be in the region of $4,000 per patient.
Current Gel Electrode Technology
Present-day electrode technology still uses the metal electrode concept discovered in the early 1950s. Since then, electrolytic gels and adhesives have been added to improve the signal quality and to stick the electrodes to the patientÔÇÖs skin. Conventional electrodes require skin preparation and regular replacement, making them less than user-friendly. The main drawbacks are skin reactions (irritations and allergies) seen on many patients mere hours after the start of the LER procedure.
No Gels and No Adhesive - A Truly Innovative Product
The Advanced Bioelectric technology turns conventional wisdom on its head by demonstrating that diagnostic ECGs can be easily performed over long periods of time using external electrodes. Their AccuHeart system is easy to use, requiring no skin preparation. As it does not use gels or adhesives, it does not cause skin irritations or allergic reactions. This technology is based on the interaction between a specially designed polymer and an electronic circuit (see Figure 3). The result is an ECG signal of high quality, even when the patient is under motion. The AccuHeart dry electrode is poised to become the new gold standard in the cardiac ambulatory monitoring business.
Current and Future Market Applications
The Advanced Bioelectric technology addresses key needs in existing long-term monitoring markets. Its first product, the AccuHeart Electrode Belt (see Figure 4a), will retrofit currently used continuous recorders as well as LERs.
The second product will combine the AccuHeart dry electrode technology with a continuous recorder (CR) or LER. The end result will be an 'all-inclusiveÔÇÖ belt (see Figure 4b) that will be easy to use and comfortable. This belt will also get rid of expensive lead wires that are often the source of many artefacts. These recording belts will improve the overall level of compliance.
The third product will be a 'Syncope BeltÔÇÖ which will resemble the LER belt (see Figure 4b) but will be specifically adapted for people suffering from syncope problems. The cost of the belt will make it affordable for healthcare systems to monitor a large number of patients with these problems.
AccuHeart - Shifting the Paradigm
AccuHeart technology is set to shift the paradigm that external long-term cardiac monitoring is not possible. Further down the road, it will be the platform for many other potential applications in the cardiac ambulatory monitoring and tele-medicine fields.
AccuHeart is a trademark owned by Advanced Bioelectric Corporation. Ôûá