Heart failure (HF) affects more than 6 million patients in the United States, with
more than 1 million hospitalizations, at a staggering annual cost of $40B.
Current standard and criteria for managing HF is largely based on clinician assessment
of symptoms and physical examination, which suffer from low sensitivity and specificity.
In addition, these modalities are not helpful at home, where patients are most vulnerable.
Furthermore, long-term patient compliance has been a persistent weakest link in the
chain resulting in poor utilization and poor outcomes.
Implantable pulmonary artery pressure monitoring (ie, CardioMEMS, Abbott Cardiovascular)
is the gold standard when it comes to remote HF monitoring. However, this approach
is expensive, complex, and suffers from low adoption, as it requires cardiac catheterization
laboratory implantation and a suite of support staff. Wearable monitors, on the other
hand, bring convenience and temporary solution; however, they are not suited for a
long-term monitoring, as the wearables have not been able to address long-term compliance
issues.
To address these limitations, Future Cardia is developing a long-term monitoring solution
that improves patient compliance and outcomes with actionable data while reducing
workloads for clinicians and—most importantly—improving patient compliance by reducing
at-home regimens.
Future Cardia uses 2 main sensors to monitor electrical and mechanical activities
of the heart, single-lead electrocardiography (ECG) to monitor cardiac arrythmias,
and 3 axis accelerometer (piezoelectric) sensors for heart sounds and activity. The
third sensor is in development.
The office-based subcutaneous insertion approach is a common procedure that allows
simple and effective device deployment and use for the clinician and patients for
the purpose of long-term monitoring.
Future Cardia’s sensing and detection algorithm assesses each heartbeat and automatically
records ECGs based on beat-to-beat instability in addition to routine recordings throughout
the day as a baseline.
The subcutaneous approach with 2-year battery longevity allows Future Cardia to deliver
actionable data to clinicians who treat patients with HF with convenience and ease.
Our goal with the trending data is to develop a simple but effective titrating algorithm,
similar to what we have seen for the patient population with diabetes: that is, for
patients to make predetermined medication adjustments under clinician supervision.
Recorded data are securely sent to the smartphone via Bluetooth Low Energy, which
is then pushed to cloud-based computing for the clinician to review via secured web
portal, similar to what the clinicians are already doing with current atrial fibrillation
insertable cardiac monitors in the market. Future Cardia has elected to keep the alerts
and notifications inactive for the time being until its utility is proved effective
for patients and clinicians (Figure 1).
Figure 1
An Acute HF Induction Recording Using Future Cardia Device at Duke University
As heart failure (HF) progresses, we can observe changes in QRS, which will allow
us to measure changes in electromechanical activation time (EMAT) and left ventricular
systolic time (LVST). In addition, we can also observe S1, S2, S3, and S4 in real
time. (A) Pre-HF induction. (B) Post-HF induction.
Limitation of heart sound auscultation is time, location, and user dependent. For
example, auscultation of pathologic heart sound (S3) in HF is time consuming and not
always present. Furthermore, some physicians simply miss it because of its infrequent
nature.
Future Cardia mitigates this limitation by recording ECG and heart sounds throughout
the day for 2 years. This method allows Future Cardia to count the number of S3 episodes
and compare it daily, weekly, and monthly for the duration of the device.
The advantage of the subcutaneous approach is that it eliminates user variabilities
and ensures precise and continuous acquisition of data. Future Cardia uses a traditional
signal processing to extract amplitude and frequency changes in ECG and heart sounds
(S1, S2, S3, S4). And because we acquire stable and consistent ECG and heart-sound
data from 1 exact location, we can calculate changes in electromechanical activation
time (EMAT), left ventricular systolic time, cardiac output, contractility, and activity-posture
over a long period of time.
After 2 years of intensive research and development, we have built a multisensor subcutaneous
insertable cardiac monitor with superior wireless technology for better connectivity
and longer vector for clearer ECG to reduce oversensing and undersensing problems.
Our first-in-men implant will start in Q3/Q4 2023 to observe patients with atrial
fibrillation and HF. And we will leverage predicate devices (Medtronic LINQ II, Boston
Scientific LUX DX) in the 510K space, with existing reimbursement to enter the U.S.
market for 2024.