Advances in Cardiovascular Diagnostic Devices

The current trends in cardiovascular diagnostics include wearables, portable monitors, remote patient monitoring and telemetry. Innovations have increased diagnosis accuracy and speed and made devices smaller, easier to use, and more comfortable to wear. Read about the trends in this Frost & Sullivan analysis.

According to the Centers for Disease Control and Prevention, heart disease is a leading cause of death for both men and women in the United States. It is responsible for 1 in every 4 deaths—more than 610,000 people every year. As disease prevalence increases—largely because of lifestyle risk factors—cardiovascular diagnostic and monitoring devices are in greater demand. The current trends in cardiovascular diagnostics include wearables, portable monitors, remote patient monitoring and telemetry. Innovations have increased diagnosis accuracy and speed and made devices smaller, easier to use, and more comfortable to wear: large, bulky electrocardiogram (ECG) devices have become pen-sized; cumbersome Holter devices with electrodes and wires have transformed into simple, disposable patches. Some of these innovations, which improve patient compliance and result in the provision of timely, quality care, are described below.

ECG Devices 

Electrophysiology-based cardiovascular diagnostic devices record and interpret cardiac electrical activity, predominantly to detect abnormal heart rhythms. ECG machines, once limited to heart stations or cardiology departments, are now found in emergency departments and electrophysiology labs. New ECG diagnostic devices offer greater mobility, better displays, and advanced software. ECG monitoring equipment and data management solutions have the potential for tremendous growth because of the shift to preventive care.

Cardiolyse, a UK-based e-health care company, has developed proprietary software with a unique ECG universal scoring system that can analyze more than 300 separate ECG and heart rate variability parameters to indicate myocardium problems and arrhythmia and evaluate psychological stress, emotional regulation and level of energy. The cloud-based processing platform uses big data analytics to predict problems. The device and software are both CE marked. Cardiolyse is looking to expand into markets with a growing aging population, such as China.

HeartCheck PEN by CardioComm Solutions Inc. (Ontario, Canada), is a handheld, 12-lead ECG device for use at home to monitor heart rhythm after a heart attack, stroke, or other cardiac event, or after angioplasty or bypass. It comes with software that allows recorded telemetry to be uploaded to the company’s C4 medical call service telemedicine group, where physicians can analyze it. It is the only device of its kind that has been approved by U.S. Food and Drug Administration (FDA) for consumer use. Bluetooth connectivity allows the device to link with Android and Apple smartphones for data acquisition.

Holter Monitors 

A Holter monitor is a portable, battery-operated, continuous heart monitoring device that can track and record heart rhythm. Technological advances have made some devices ultralight and attachable to the skin with adhesive, wireless electrodes. These new ambulatory ECG monitors give patients more freedom for daily activities, and are capable of transmitting data through mobile apps to physicians.

BodyGuardian Holter by Preventice Solutions Inc. (Houston, Texas) can monitor patients for as long as 30 days. It has an easy-to-read monitor that receives data wirelessly from the rechargeable device, which uses a disposable adhesive patch that attaches directly to the skin. The device is FDA approved and CE marked.

ScottCare Cardiovascular Solutions’ (Cleveland, Ohio) novi patch Holter monitor allows quick identification of abnormal heart rhythms and reduces patient preparation time required by traditional Holter monitors. When attached to the sternum, the novi begins recording immediately and automatically shuts off upon removal. The novi patch unit is less than 2 inches in length, lightweight, wire-free, and water resistant, and uses a rechargeable, built-in battery. The device is expected to improve patient compliance due to its discreet appearance and ease of use. It can record for up to 72 hours utilizing a single disposable patch electrode.  The novi patch Holter monitor is FDA approved and CE marked. The ScottCare suite of solutions includes proprietary algorithms for accurate heart rhythm diagnosis.

Zio Patch by iRhythm Technologies (San Francisco, Calif.) is an adhesive, water-resistant, one-lead ECG sensor Holter monitor that can affix to the chest for 24-hour monitoring over 2 weeks. The patch contains hydrogel electrodes and requires no battery change by patients. Powerful analytics interpret large volumes of patient data and provide patterns that help doctors diagnose heart rhythm issues without requiring additional testing. 

The InfoBionic (Lowell, Mass.) MoMe Kardia system is the first and only wireless remote patient monitoring platform that incorporates Holter, event, and mobile cardiac telemetry technologies into a single sensor and transmitting device. It uses the cloud to deliver actionable, on-demand results directly to physicians with a software-as-a-service remote cardiac monitoring platform that replicates in-hospital monitoring with full disclosure of cardiac data.

Implantable Cardiac Monitors

An implantable loop recorder is a subcutaneous, single-lead ECG monitoring device implanted in the left parasternal region for diagnosis and long-term monitoring of patients at risk of or with atrial fibrillation, asymptomatic arrhythmias or myocardial infarction. Miniaturization has allowed devices to be implanted through minimally invasive procedures. Implants in the left upper chest area—midway between the supraclavicular notch and the left breast area—have improved device performance. Other improvements are giving devices enhanced storage capacity and making them compatible with different imaging techniques so that data capture is not disturbed. The new-generation implantable cardiac monitor can automatically detect any kind of arrhythmic event without active intervention by the patient.

The Reveal LINQ Insertable Cardiac Monitor by Medtronic plc (Dublin, Ireland) is the smallest implantable cardiac monitoring device—one-third the size of an AAA battery. It can automatically detect and record abnormal heart rhythm for up to 3 years. Through MyCareLink Monitor, the collected heart rhythm data is shared with a physician using a cellular network or Wi-Fi. Reveal LINQ shows accuracy of 99.4% in atrial fibrillation detection.

BIOTRONIK International’s (Berlin, Germany) BioMonitor implantable cardiac monitor is a small, pacemaker-shaped device. To initiate a recording, a magnet is placed over the implanted BioMonitor for 1 to 2 seconds. It uses ClearSense technology’s three-vector signal detection for precise and reliable arrhythmia monitoring. The device is integrated with the BIOTRONIK Home Monitoring system, which transmits all data to a physician wirelessly. Until recently, implant patients could not undergo MRI scans due to the negative effects of strong magnetic forces on implant devices. This FDA-approved, MRI- compatible device uses ProMRI technology that allows patients to have 1.5 or 3 Tesla MRI scans essential for diagnosing stroke, tumors, or orthopedic injuries.

The CardioMEMS HF System by St. Jude Medical (Saint Paul, Minn.) is the first and only FDA-approved heart failure monitoring system that measures and monitors the pulmonary artery pressure and heart rate in Class III heart failure patients who have been hospitalized for the condition in the previous year; hemodynamic data are used by physicians to manage heart failure and reduce hospitalizations. 

Endotronix Care Management Solutions by Endotronix Inc. (Lisle, Ill.) consists of battery-less, implantable sensors that measure the pulmonary artery pressure data to determine the progression of cardiovascular disease. A handheld device held close to the chest gives the pulmonary artery pressure instantaneously. This and other health data, such as heart rate and comorbidities, are wirelessly and securely transmitted to the cloud to help clinicians deliver therapy while a patient is at home. The product is in clinical trials. 

What’s the Future?

Due to the growing complexity of cardiovascular diseases with multiple problems in the heart, the method of diagnosis is also changing. Demand for predictive, personalized health care can be met not only through remote patient monitoring or mobile cardiac telemetry, but by integrating products and services with hospitals’ electronic health record systems. Using cloud interfaces for data sharing or predictive analytics can help patients and physicians detect cardiovascular risks, ultimately reducing complications, health care costs, and mortality. Companies are integrating event and Holter monitoring into a single device. 

Innovations in nano- and microelectromechanical systems and wireless communication have helped diagnostic devices become smaller, easily implantable, and more comfortable to wear. Patients are becoming empowered to track and manage their own health, and health care is becoming more personalized through interventions tailored to individual patients.

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