Innovative device includes clinical-grade measures for heart stroke volume, blood pressure, and peripheral blood oxygenation.
If a new device embedded in a toilet seat secures FDA approval, detecting heart failure in high-risk patients could be as simple as a trip to a patient's home bathroom rather than involving the cost and delay of medical tests.
Sounds preposterous? It doesn't appear to be. The accuracy of device, conceived years ago by a graduate student and his advisor at Rochester Institute of Technology (RIT) in Rochester, New York, has been confirmed in a peer-reviewed article published January 18 in JMIR Mhealth Uhealth.
The study validated the high-tech seat is capable of clinical-grade measures for systolic and diastolic blood pressure, peripheral blood oxygenation, and heart stroke volume. Currently, according to the inventor, the latter measure is only possible through ultrasound, a cardiac MRI, or catheterization, which is an invasive procedure.
Unlike wearable devices, which require recharging and usage is sometimes abandoned, the toilet seat involves no change in patients' habits. It also provides substantial skin contact, which is necessary for accurate readings, and enables regular monitoring because it is incorporated into an activity that is already part of an individual's daily routine.
"The toilet seat, while crazy, ends up being a perfect solution," says Nicholas Conn, founder and CEO of Heart Health Intelligence. Conn developed the complex circuitry, programming, instrumentation, cloud architecture, and algorithms behind the innovation as part of his graduate studies under the supervision of David A. Borkholder, PhD, Bausch and Lomb Professor of Microsystems Engineering at RIT.
Why Should Health Systems Care?
Heart failure is a costly and growing problem in the U.S., and contributes significantly to hospital readmissions.
- In an article published in Circulation on January 24, 2011, direct medical costs for heart failure were expected to increase from $24.7 billion in 2010 to $42.9 billion in 2020. By 2030 costs are predicted to rise to $77.7 billion, a 215% increase in a 20-year period.
- The same article indicated crude prevalence of heart failure, which is not age-adjusted, is expected to rise from 2.8 million in 2010, to 3.1 million in 2020, and 3.5 million in 2030. People older than 65 years of age (especially those more than 80 years of age) have a higher prevalence for all forms of cardiovascular disease, notes the study.
- According to Heart Health Intelligence, more than 45% of heart failure patients are readmitted within 90 days of discharge. Of $528,000 per year in government penalties for readmissions, heart failure is the leading cause.
Inside the Device
The cardiovascular monitoring system in the toilet seat includes an integrated electrocardiogram, ballistocardiogram, and photoplethysmogram. It measures the electrical and mechanical activity of the heart, including:
- Heart rate
- Blood pressure
- Blood oxygenation levels
- Patient’s weight
- Stroke volume, which is the amount of blood pumped out of the heart at every beat
Algorithms analyze the data, and with further development, the inventor hopes to create a method to alert advanced practice providers of a deteriorating condition.
The device "successfully demonstrated with blood pressure, stroke volume, and blood oxygenation, accuracy consistent with gold standard measures," according to the journal article. "This system will be uniquely positioned to capture trend data in the home that has been previously unattainable. Demonstration of the clinical benefit of the technology requires additional algorithm development and future clinical trials, including those targeting a reduction in heart failure hospitalizations."
Birth of an Idea Designed to Maximize Adherence
While the use of wearable technology and home monitoring devices is growing, one of the greatest challenges is compliance and getting patients to adhere to a routine, says Conn.
"Only 9% of [heart failure] patients monitor themselves for symptomology, let alone track measurements, such as weight and blood pressure," says Conn. "Only 14% will weigh themselves every day," which is a physician-recommended practice for these patients.
"Even the most well-meaning patients will have trouble every single day without fail measuring their blood pressure accurately," he says. "It's just not going to happen. And especially when we start talking about less compliant populations, we realized that we had to integrate technology into an item that people use every day."
Initially, the academic team considered embedding technology into a computer mouse or the steering wheel of a vehicle, but realized a patient with advanced cardiovascular disease might not routinely use these devices.
"There was a real need for integrating [our device] into the home environment. Every single person goes to the bathroom every single day; it's automatic," says Conn. "There's no behavior change required," he says, and it offers a natural opportunity for skin contact with the device's sensors.
While he's endured endless jokes about his high-tech bathroom seat over the years, Conn explains that compliance was the genesis of the "toilet concept."
As research progressed, it turned out a toilet seat also is an ideal way to measure the force of the heart ejecting blood, because the slight up and down force on the torso it creates can be measured in the seated position.
With Additional Clinical Validation, the Device Could Have Other Uses
The next focus of business will be to obtain FDA approval, a process that Conn expects to take two to three years. Meanwhile, the company he's formed is seeking regulatory and commercialization partners, as well as clinical partners for additional testing.
It's been very important for us, from the beginning, to do this with clinical evidence," he says. He doesn't want his invention to go down the toilet, so to speak, the route many other innovative devices have taken when the promise doesn't hold up to the hype.
"We're well along our way of validating this; he says. "It's not a pie in the sky dream."
The device has potential uses beyond detecting heart failure, Conn says. The data it gathers could prove beneficial for understanding of overall heart health and other types of cardiovascular disease. In fact, the company is engaged in discussions with MD Anderson Cancer Center representatives to determine if it can be used to detect deterioration of heart function in breast cancer patients whose hearts may have been damaged by chemotherapy and radiation.
"We're starting with heart failure," Conn says of the company's initial focus. "That's not where we'll stop."
“"The toilet seat, while crazy, ends up being a perfect solution," says Nicholas Conn, founder and CEO of Heart Health Intelligence.”
Mandy Roth is the innovations editor at HealthLeaders.
Photo credit: A. Sue Weisler, Rochester Institute of Technology
Use of everyday device overcomes challenges related to compliance and adherence.
Seat is capable of clinical-grade measures for heart stroke volume, blood pressure, and peripheral blood oxygenation.
Data gathered by device could prove beneficial for understanding overall heart health and other types of cardiovascular disease.