Designs that prioritize comfort and accuracy are essential to ensuring patient compliance with wearable defibrillators during the critical post-discharge period.
Summary: The importance of innovative design and comfort in wearable cardioverter defibrillators is critical for ensuring patient compliance during the hospital-to-home transition after a cardiac event. Traditional wearable cardioverter defibrillators have faced challenges such as discomfort, bulkiness, and high rates of false alarms, which can lead to suboptimal patient use. Recent advancements in the field, such as the development of adhesive-based wearables, aim to address these issues by offering more user-friendly designs and incorporating technologies like AI for more accurate heart rhythm monitoring.
Key Takeaways:
- Challenges with Traditional WCDs: Traditional wearable cardioverter defibrillators often face issues like discomfort, bulkiness, and frequent false alarms, which can negatively impact patient compliance.
- Jewel P-WCD as an Example of Innovation: The Jewel Patch Wearable Cardioverter Defibrillator (P-WCD), currently an investigational device in the United States, represents an advancement in the field, featuring a more lightweight, discrete design that allows continuous use, including during activities like showering, addressing many of the limitations of earlier devices.
- Improved Compliance and Accuracy with AI: The Jewel P-WCD incorporates AI technology to enhance heart rhythm monitoring accuracy, reducing false alarms and improving patient compliance.
By Trevor Bromley
When an individual is discharged from the hospital after a cardiac event or with certain diseases that affect the heart, such as a heart attack or heart failure, they are often at risk for experiencing a lethal heart rhythm and sudden cardiac arrest within the first few weeks to months. The need for constant surveillance of the heart during the hospital-to-home transition means compliance with wearable defibrillators is necessary for patient safety and longevity.
For the past couple of decades, many patients have been aided, if imperfectly, with electrode-fitted vests that patients wear tightly around their torsos. These wearable defibrillators are often uncomfortable and bulky, can cause false alarms that can lead to inappropriate shocks, and require daily unprotected time when they are removed for certain activities.
The challenges to continuous use include daily removal for showering, recharging, and cleaning. Other barriers like complicated setup, a bulky form factor, and a high rate of false alarms due to the device mistaking outside noise for abnormal heart signals have led to suboptimal compliance.
Failure to wear the product leaves patients vulnerable, and, therefore, a gap has existed in the market. There is a need for a user-friendly wearable device that is discrete, effective, and has a high accuracy rate to decrease the number of false alarms while ensuring patients are appropriately shocked at the time they are most in need.
Patients make the choice each day to use the wearable device or not. Companies are increasingly aware that, to ensure compliance, they must design and develop wearables patients can comfortably use daily and, in many cases, without interruption.
Ensuring Compliance
The Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)—currently an investigational device in the United States—is an example of a Class III medical device designed with the user in mind. It is built to ensure discrete visibility while utilizing the latest technological advances to ensure accuracy, resulting in fewer false alarms. Element Science developed this adhesive-based wearable defibrillator with a user-centric design and advanced features like the accurate classification of heart rhythm using machine-learning artificial intelligence (AI).
The device weighs less than one pound and consists of two patches that sit in the two parts of the body where a defibrillator would traditionally be placed, creating an energy vector through the heart at the time of a shock. The water-resistant design allows users to shower while wearing the device, and the discrete and form-fitting nature of the product makes it easy for users to sleep with the device and move freely and discretely in public.
[RELATED: Wearable Cardioverter Defibrillator Reduces Risk of Sudden Cardiac Arrest]
Additionally, the Jewel P-WCD is designed to be used continuously for up to a week without requiring maintenance. When a doctor prescribes the device, a representative guides the patient on proper placement using a personalized harness accessory that wraps around the individual’s torso. The device loads into the harness, allowing the patient to have individualized placement each time the patches need replacement. Once placed appropriately, the patient can remove the harness and go about their lives as usual.
During a clinical evaluation of the Jewel P-WCD, subjects at high risk for sudden cardiac arrest had a median compliance rate of 97.8% with 23.5 hours of median daily protected time and were able to wear the device continuously for over five days. 91% of participants wore the P-WCD for longer than the prespecified threshold of 14.1 hours per day.
Employing AI Technology
The device uses AI to monitor and interpret the innate details of a patient’s heart rhythm signals and can better detect which features of the signals correlate with a lethal rhythm and which do not, essentially creating a binary classifier.
The proximity of the patches on Jewel, sitting directly on a patient’s chest, allows for high sensitivity and more accurate readings as it diminishes outside noise and captures a clearer picture of the ever-so-slight variations in heart rhythm signals. Direct contact allows the AI to “hear” the heart’s rhythm in more detail, allowing it to better determine whether a patient needs a shock.
Additionally, machine learning algorithms allow the device to interpret that signal on a real-time basis with a greater rate of accuracy. The Jewel research study showed P-WCD had no median false alarms per month compared to three per month with the leading vest product, and 88.9% of patients had less than one alarm per day.
More than half of the study’s participants, 61.7%, experienced no alarms daily, and another 22.7% of patients experienced less than one alarm per day. Zero deaths were reported in the Jewel study, and six lives were saved with eight single conversions. One patient experienced three different episodes of arrhythmia that were successfully converted.
The AI algorithm used within Jewel continues to learn new patients’ heart rhythms and signals over time.
Conclusion
Technological advancements in material science, electronics, AI, and wearables have paved the way for a new generation of advanced wearables like Jewel P-WCD to be comfortable and deployable enough to ensure consistently high levels of compliance and save lives.
In January, Jewel received the European Union’s CE Mark certification and Great Britain’s UK Conformity Assessed marking. Element Science is seeking premarket approval from the US Food and Drug Administration.