Background
Chronic Heart Failure with Reduced Ejection Fraction (HFrEF) is a pervasive condition characterized by the heart’s inability to pump blood efficiently. This inefficiency leads to systemic repercussions, including reduced perfusion of the organs and potential acute events due to inadequate cardiac output. Among the physiological responses to heart failure is systemic vasoconstriction — a compensatory mechanism aimed at maintaining blood pressure despite weakened cardiac power. However, prolonged vasoconstriction contributes to a detrimental cycle, exacerbating heart workload and impairing tissue perfusion.
In response to these challenges, Angiotensin Receptor-Neprilysin Inhibitors (ARNIs) have emerged as a pivotal treatment in managing heart failure, particularly beneficial for patients with chronic heart failure regardless of whether it is due to reduced (HFrEF) or preserved (HFpEF) ejection fraction. ARNIs not only help to alleviate vasoconstriction but also enhance natriuretic peptides which are natural substances that promote vasodilation and excretion of sodium. This dual-action therapy significantly helps in reducing preload and afterload on the heart, improving cardiac output, and thereby potentially reversing the adverse effects of chronic vasoconstriction. The ability of ARNIs to target these underlying pathophysiological mechanisms in heart failure makes them especially beneficial to this patient base.
Currently, the gold standard for assessing patient compatibility with this medication involves directly measuring Systemic Vascular Resistance (SVR) via invasive catheterization — a procedure that, while accurate, can pose risks such as bleeding, infection, and arterial damage. This level of invasiveness and associated risks makes routine screening impractical, particularly for a condition that requires frequent monitoring to guide medication adjustments. Furthermore, less-invasive screening methods such as the touch test for peripheral vasoconstriction are subjective and heavily reliant on practitioner expertise, which varies widely and may lead to inconsistent assessments. The lack of a standardized non-invasive screening method for evaluating vasoconstriction severely limits the ability to optimally manage heart failure and personalize treatments, particularly concerning the prescription of Angiotensin Receptor-Neprilysin Inhibitors (ARNIs) which have shown increased efficacy in heavily vasoconstricted patients.
Project Scope
Thus, there is a need for a reliable, non-invasive diagnostic tool to accurately assess systemic vasoconstriction. This tool is imperative for optimizing the management and treatment of heart failure, particularly for enhancing the prescription efficacy of ARNIs in early screening. The main goal of this project is to produce a standardized diagnostic method that reduces the risks and limitations associated with current invasive techniques while improving clinical outcomes and patient quality of life.
To address this need, the project will focus on several key customer requirements:
- Accuracy and Reliability: A cardiologist must be able to reliably use the results to guide ARNI therapy adjustments accurately.
- Non-invasiveness: The tool will minimize patient discomfort and the risk of complications associated with cathaterization, making frequent assessments more feasible.
- Usability and Accessibility: The tool should be easy to use and interpret by healthcare providers, requiring minimal training. This will ensure widespread adoption and consistent use across various healthcare settings.
- Cost-effectiveness: Designing the tool to be cost-effective will ensure that it can be widely implemented without significant financial burden to healthcare systems.
Key Stakeholders
Notably, regulatory agencies and healthcare providers are the most powerful and interested in our device since they are directly related to its mission statement and clinical implementation. Insurance companies and heart failure patients are close behind with serious financial and health considerations. We will manage these stakeholders closely, and make sure to get their input every step of the way.
Industry partners, mentors, and pharmaceutical companies are all very interested in our efforts but do not have much direct influence on our work. We will keep these stakeholders informed. Investors and suppliers are critical to our efforts but are not as directly interested in the day-to-day operations and direction of our project. We will aim to keep these stakeholders satisfied. Finally, competitors and heart-failure researchers have low interest in our work or influence on our project, but should still be monitored.
Design Specifications
| Design Specifications | Metrics | Metric Justification |
| Volume | < 500 cm^2 | Ensures the device is compact enough for easy handling and portability, suitable for both clinical and at-home use. |
| Weight | < 500 g | Enhances user comfort and facilitates longer use without fatigue. |
| Heart Rate Measurement Error | < 10% | Guarantees sufficient accuracy for clinical decision-making |
| Heart Rate Measurement Variation | < 10% | Ensures consistency and reliability of heart rate measurements across multiple uses and conditions. |
| Blood Pressure Measurement Error | < 10% | Maintains clinical relevance and accuracy, providing confidence in non-invasive blood pressure assessments. |
| Blood Pressure Measurement Variation | < 10% | Critical for monitoring and adjusting treatment plans, ensuring patient safety and effective management. |
| Skin Temperature Measurement Error | < 10% | Ensures accurate readings crucial for assessing metabolic and circulatory health in heart failure patients. |
| Skin Temperature Meausrement Variation | < 10% | Important for reliable monitoring of changes over time, especially in response to treatment. |
| Setup Time | < 10 min | Facilitates quick deployment in various settings, increasing the efficiency of healthcare delivery. |
| Battery Life | > 5 hrs. | Ensures the device can last through a typical usage period without recharging, enhancing usability. |
| Manufacturing Cost | > $100 | Keeps the device affordable to produce, aiming for broad accessibility and adoption in healthcare systems. |
Existing Solutions
Design Schedule
Team Responsibilities
Our team is very dynamic with a flat structure. We all have complementary skill sets and plan on offering and providing assistance to all group members whenever possible. The following group members will, in general, ensure the following processes are on schedule by prompting all group members:
- George Mitrev– Design/Development
- Parker Murphy – Documentation/Reports
- Leo Liu – Research
- Jared Zane – Testing