In this interview, we speak with Dr. Marek Dziubinski, scientist and CEO of MEDICALgorithmics, about the PocketECG mobile cardiac telemetry system.
When and why was the PocketECG mobile cardiac telemetry system created? Describe some of the limitations in current arrhythmia detection and diagnostic methods.
We created PocketECG at a bit of an inflection point. While physicians were happy with Holter monitoring for 24- to 48-hour cardiac monitoring and with the high quality of the reports they were receiving, it became very clear that certain procedures and situations required longer term patient monitoring, necessitating mobile solutions. Many of our competitors developed products designed to capture the ECG at infrequent intervals as well as extrapolate potential arrhythmia statistics and features based on the limited signal samples. We went the opposite direction. We thought, why not classify every heartbeat and stream all of the data to provide a level of statistical analysis that no one can match? So this is what we did.
PocketECG transmits, discloses, and labels every heartbeat, enabling efficient, full statistical ECG analysis and complete, easily accessible reporting. We detect all ventricular and supraventricular arrhythmias, including detection of individual PVCs or PACs. Also, we provide access to the onset and offset for every arrhythmia episode. These are unique features of our technology that make precise diagnosis possible, even for the toughest arrhythmia cases.
We engineered PocketECG to do more than other mobile monitoring devices so that it has real value for cardiologists and specialists. Some of these features include:
- Morphology-based analysis of ventricular, supraventricular (including AF), and other types of arrhythmia;
- Comprehensive AF rate and sinus rate analysis at rest and during patient activity;
- Web-access to full-disclosure ECG;
- Full statistical reporting that includes PVC count, PAC count, atrial fibrillation (AF), and sinus rhythm;
- Complex arrhythmia reporting that includes short and long supraventricular and ventricular runs, bigeminies, trigeminies, and many more;
- Reporting extreme examples of each arrhythmia type (e.g., the fastest and the longest supraventricular and ventricular runs, the slowest bradycardia, the fastest and longest AF, the longest pause and asystole, etc.).
Tell us about the PocketECG mobile cardiac telemetry system and its components. How is it used by the patient?
Roughly the size of a smartphone, PocketECG is a single lightweight, user-friendly mobile monitoring device, prescribed by a cardiologist or electrophysiologist to monitor an arrhythmia patient’s heartbeat for up to 30 days.
From the patient perspective, PocketECG is easy to use. Three leads connect Pocket ECG to the patient’s chest. The device then provides a constant stream of ECG data, transmitting and disclosing every beat, while wearers go about their daily lives. Patients can track their symptoms such as chest pain, dizziness, or heart palpitations with the touch of a screen.
Because PocketECG consists of a single device to collect, store, and transmit data, patients don’t have to worry about Bluetooth pairing, a lost connection between devices, or battery maintenance for multiple components. Patients can also easily relocate skin electrodes in the event of irritation.
Discuss PocketECG’s capabilities, including the new activity monitoring through the built-in accelerometer.
Some arrhythmias may cause a fast heart rate that may require pharmacological treatment. The most common is AF. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation indicate that the rate should be measured both at rest and during exercise in patients with persistent or permanent AF before using rate-controlling medication. Until now, patients had to manually log their activity during arrhythmia monitoring so that the physician could roughly correlate the heart rate changes with the patient’s physical activity. The built-in accelerometer objectively and continuously monitors the patient’s activity. It will enable health care professionals to differentiate between heart rate changes triggered by physical activity and those triggered by an arrhythmia. The new feature will also allow them to determine the correlation between the patient’s physical activity, their symptoms, and various types of arrhythmia.
Many cardiac conditions cannot be diagnosed with a single ECG test or by using standard diagnostic methods of arrhythmia detection. PocketECG makes precise diagnosis possible through full disclosure monitoring of a patient’s heart rhythm for up to 30 days, labeling and classification of every heartbeat, and true statistical analysis. This ability, when combined with physical activity monitoring, allows us to provide better correlation data and enable specialists to derive more meaningful HR measurements to improve treatment decisions.
Where is the monitoring data sent to for analysis?
The monitoring data is sent to one of our service centers staffed with EP technicians. Algorithms on the device run full statistical analyses and transmit the full disclosure ECG signal, which allows the monitoring center to generate the diagnostic reports that are available through our online portal. Doctors and nurses can also view online the incoming continuous ECG signal, with all heartbeats labeled.
How often are reports generated? Tell us about what is included on the report, including the arrhythmia detection results as well as the new physical activity analysis section.
Urgent and important reports are published on an ongoing basis, while the daily reports are generated every 24 hours. The End of Study (EoS) report is published at the end of monitoring. Figure 2 shows a sample EoS report, so you can see the depth of information we provide to electrophysiologists and cardiologists.
The front page of our report has been designed to give the physician everything that he or she needs to know: statistical information on the leading rhythms and arrhythmia (pie chart), the most important statistics per each arrhythmia category supported by the extreme (most important) ECG examples, and statistical summary of the patient’s symptoms and arrhythmia correlated with symptoms.
All other pages dig deeper into statistics and allow the physician to explore details, but are not necessary to make the diagnosis (they are in fact optional, and the report can be configured to not include these pages. So far, however, no single physician has asked us to remove any of the pages, because having them always gives the option to dig deeper).
In the event of an urgent arrhythmia, our EP technicians immediately notify the attending cardiologist or electrophysiologist.
When did PocketECG receive FDA approval?
The latest version of the PocketECG system received clearance to market in the U.S. in October 2015.
How does PocketECG affect patient care and hospital savings?
PocketECG provides more complete information at the point of care and ensures accurate diagnosis with complete data capture and reporting, which in turn guides better treatment decisions. This translates into effective treatment for the patient as well as improved hospital efficiency.
Where is PocketECG now being used?
PocketECG is being used throughout the U.S., Canada, South America, Europe, Asia, and Australia.
What’s next for MEDICALgorithmics and Medi-Lynx? What other technologies are in development?
With our recent acquisition of a majority stake in Medi-Lynx Inc., the U.S. service provider of our technologies, we’ll be looking to expand the PocketECG market and presence in the United States. The company is also developing several other products, including a device for cardiac rehabilitation, software for optimizing repetitive tasks in hospitals, and algorithms for remote interpretation of multi-lead electrocardiography signals.