MedGizmo - MedGizmo: Wearables and Heart Failure
01.02.2016, 09:44   MedGizmo

MedGizmo: Wearables and Heart Failure

When talking about wearables, the majority of people think mostly about fitness trackers, Apple Watch, etc. However, the fact that medical wearables can track health and vital signs open new horizons in their implementation. More and more consumers are using their wearables to measure their own blood for cholesterol or take EKG (I am using Live Core for it daily). In this post we are attempting to have a look at wearables that can prevent Heart Failure.

Heart failure (congestive heart failure - CHF), is actually ineffective heart. Generally, people mistakenly believe that heart failure is an abrupt stopping of the heart. In reality this condition usually takes place over time. It happens when the heart is not pumping properly: it is unable to contract or relax. As a result, the heart can’t pump enough blood to meet your body’s needs.

For heart failure, biomarkers (blood pressure, body weight) are extremely important when assessing the severity of a disease. Thus, here is a good opportunity to equip a patient with the proper wearable, and through it control the problem.

However, mHealthIntelligence in their recent post Wearables Can Help People With Heart Conditions - If Only They’d Wear Them rightfully notes that “… three-quarters of people with known heart disease and/or risk said the activity tracker they’re using is helping them. However, of the 501 people surveyed this month, only 27 percent are using trackers, and only 16 percent are using them to manage their heart health.”

We cannot compare with this brilliant description of physiology of Heart Rate, as well as Hardware and Software 101 in this work by James Watson – which is highly recommended for reading
Digital health – health and fitness wearables, Part 3: Heart Rate Variability: Principles and Science and Practical Measuring Devices
Nevertheless, let us have a brief look at available solutions

CardioMEMS™ HF System
The CardioMEMS™ HF System is the first and only FDA-approved heart failure (HF) monitoring system proven to significantly reduce HF hospital admissions and improve quality of life in NYHA class III patients.


Here is a brief Note on the system
And the post by Houston Chronicle
New device implanted in pulmonary artery senses trouble before it hits
A tiny device that measures pressure in the pulmonary artery is helping patients monitor symptoms of heart failure - and is keeping them out of the hospital.
The device, called CardioMEMS, is about the size of a little paperclip and is implanted in the blood vessel via a catheter. It is a small sensor that uses no battery or power, according to Dr. Arvind Bhimaraj, a cardiologist with Houston Methodist Hospital's Heart and Vascular Center
Read the full story HERE

Oxxiom single-use pulse oximeter
True Wearables, Inc., a medical device start-up based in Orange County, CA, makes Oxxiom, the world's first wireless, continuous, fully disposable, single-use pulse oximeter. Oxxiom measures arterial oxygen saturation (SpO2), pulse rate (PR), and perfusion index (PI). True Wearables' innovative design has combined the electronics and biosensing technology of a clinical grade pulse oximeter into a tiny, easy-to-use, and completely wireless device that offers over 24 hours of continuous monitoring. Oxxiom weighs only 0.12 ounces (3.5 grams) and is completely disposable, eliminating the need for sterilization and significantly reducing the risks of cross contamination.
Oxxiom is expected to ship in Q2 2016. Oxxiom is not yet cleared by the FDA for clinical use as a medical device.

ZOLL LifeVest wearable defibrillator
The LifeVest wearable defibrillator is worn by patients at risk for sudden cardiac arrest (SCA), providing protection during their changing condition and while permanent SCA risk has not been established. The LifeVest allows a patient’s physician time to assess their long-term arrhythmic risk and make appropriate plans. The LifeVest is lightweight and easy to wear, allowing patients to return to their common activities of daily living, while having the peace of mind that they are protected from SCA. The LifeVest continuously monitors the patient’s heart and, if a life-threatening heart rhythm is detected, the device delivers a treatment shock to restore normal heart rhythm.


Pulsewave® Health Monitor by Cloud DX

Pulsewave® is designed to be used to collect vital signs in the clinic, and also to be sent home so doctors can follow up remotely. It is the only FDA cleared, clinical & consumer health monitor that displays the actual heart beat in real time, derives 4 biological results from each noninvasive wrist cuff reading (Heart Rate, Blood Pressure, Respiration Rate and our unique Cardiac Anomaly Scores), includes statistical Confidence Intervals around key readings including Blood Pressure and Respiration, indicating the level of precision for each reading and allowing a user to re-take a reading that may be too imprecise to count.


VITALITI Tricorder
 This is another product of Cloud DX that combines all of their developments
The Cloud DX entry in the Qualcomm Tricorder XPRIZE consists of four interdependent wireless devices connecting to an advanced mobile app running on a smartphone.
  •     Wearable Vital Sign Monitor
  •     Wireless Spirotoscope
  •     In Vitro Diagnostic System
  •     Pulsewave Health Station
VITALITI™ continuous vital sign monitor is designed to be the ultimate consumer wearable device, so comfortable you forget it’s even on your body, yet capable of tracking 5 vital signs with clinical accuracy over a minimum of 72 hours. Testing to date has shown that VITALITI is comfortable to wear throughout the day, and can even be worn continuously as you sleep. This level of comfort will make VITALITI a valuable tool for motoring chronic conditions that worsen at night, including COPD, Congestive Heart Failure and Sleep Apnea.


Titan Wireless Implantable Hemodynamic Monitor (WIHM)


Titan Wireless Implantable Hemodynamic Monitor (WIHM) is the world’s most accurate and intelligent, non-invasive, miniature implant.
This what NASA writes about it:
Wireless, implantable cardiovascular system sensors developed to help NASA's Glenn Research Center (GRC) better understand blood flow in astronauts during spaceflight are now finding success in clinical trials as a key device to help monitor patients with congestive heart failure (CHF) and to manage their condition. Developed by Integrated Sensing Systems, Inc. (ISSYS), the Titan Wireless Implantable Hemodynamic Monitor (WIHM) uniquely measures the pressure of the left side of the heart (both left atrium and left ventricle), as well as any location in the cardiovascular system, including the pulmonary artery. ISSYS WIHM has also been used with left ventricular assist devices (LVAD). Based on microelectromechanical system (MEMS) technology, these devices provide cardiac wave pressure measurements and ventricle filling pressure—significant parameters for the management of CHF. Data is provided on demand via a remote monitoring feature that enables home monitoring and remote healthcare provider management, allowing providers to adjust medications as needed, and assisting with real and false emergencies. Clinical trials in Europe have shown positive results for both efficacy and safety, and ISSYS has plans to test the devices in pediatric patients in 2015, as well as begin clinical testing for intra-cranial pressure monitoring.
Picture: NASA

ISS’ Titan IHM implant has been designed to have significant clinical and technical advantages over the currently marketed implantable hemodynamic monitor, including its ability to monitor the left side of the heart. The main goal of tailored medication for CHF patients is to maintain a fine balance between improving cardiac output (blood flow pumped by a ventricle) and sustaining a reasonable left-heart filling pressure. Therefore, left-heart pressure waveforms are the most desirable parameters for the management of patients with cardiovascular problems, since unlike using pulmonary artery pressures, left filling pressure is not adversely affected by common pulmonary comorbidities such as pulmonary embolism. Monitoring the left heart is, however, very challenging due to the stringent biocompatibility and hemodynamic requirements of the left heart.
ISS is developing two categories of products: IHM sensors that are implanted adjunct to a planned thoracic surgery and implants that are delivered percutaneously via catheter-based techniques in either the pulmonary artery (PA) or left atrium during a stand-alone procedure. Titan IHM is composed of three components: a Telemetric Implant, a Monitoring Unit, and the Database Management system for internet-based worldwide access.



CoVa™ Monitoring System
toSenseTM is developing the CoVa™ Monitoring System, featuring a novel body-worn Sensor for at-home patients with chronic illnesses, such as congestive heart failure (CHF), chronic obstructive pulmonary disease, hypertension, and renal failure. Worn like a conventional necklace for just minutes each day, the Sensor measures thoracic bioimpedance and electrocardiogram waveforms, and from these calculates a thoracic impedance, heart rate, heart rate variability, and respiration rate. The same hardware, augmented with next-generation versions of firmware, will measure additional vital signs and hemodynamic properties such as stroke volume and cardiac output.

Electronics that measure these parameters are embedded within the Sensor, resulting in a comfortable, easy-to-use device with no external wires. The Sensor is designed for older patients, emphasizing usability with such features as a magnetic clasp to turn the Sensor on, magnetic electrodes, and simple wireless data transmission.
FDA cleared it for marketing in May 2015, and the device, worn as a necklace, can be worn for just a few minutes a day to measure thoracic bioimpedence and electrocardiogram waveforms and then calculate thoracic fluid index, heart rate, heart rate variability, and respiratory rate.


 
01.02.2016, 09:44   MedGizmo
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