Wednesday, December 4, 2024

QUICKIPEDIA: INTRODUCING THE HEARTREADER (short & friendly version)

 

In October 12/13, 2024, HealthTech Reporter met with Dr. Sándor Kulin (developer of the HEARTREADER from Budapest, Hungary) at the Holistic Health Educational Expo in North Bergen, NJ. (see expo group). In this issue of HealthTech Reporter, we feature the concept behind of Dr. Kulin's innovation as a medical-grade scanning solution designed to generate reports and scores to support treatment response and estimating cardiovascular age. 





Functions on-demand of the HeartReader 

By: Dr. Sándor Kulin

Source: HeartReader marketing

Peripheral pulse wave analysis is a well-established scientific method for evaluating an individual's hemodynamic status. However, transforming this methodology into a clinically applicable tool requires innovation and dedication. This is precisely the mission at HeartReader™: to develop and implement a robust system that bridges the gap between foundational research and practical healthcare applications.

HeartReader’s Core System and Scoring

HeartReader is built on more than 30 parameters derived from scientific literature, alongside a composite Total Score that provides an overall evaluation of cardiovascular health and risk levels. As noted by Professor Sengupta of Rutgers University, cardiovascular disorders remain the leading cause of death globally, emphasizing the urgent need for reliable tools to assess individual risk. Esteemed cardiologists and specialists acknowledge that HeartReader may be the first system to meet this critical need effectively.

In addition to the Total Score, HeartReader offers a series of specialized subscores, each targeting specific aspects of cardiovascular and overall health:

    Cardiovascular Health Score
Assesses the aging speed of the arterial system and the heart, offering insights into vascular health over time.

    Blood Pressure Score
Similar to HbA1c for blood sugar, this score identifies potential blood pressure issues over recent months rather than providing real-time measurements. A high score suggests lower cardiovascular risk, while a low score indicates potential concerns.

    Heart Fitness Score
Evaluates physical capacity and cardiovascular exercise tolerance, reflecting an individual’s ability to endure physical activity.

    Metabolic Fitness Score
Offers insights into cellular health, focusing on mitochondrial function. Through collaborations with experts in deutenomics (the study of deuterium content in mitochondria), this score provides an indicator of mitochondrial health and energy production efficiency.

    Cardiac Stability Score
Measures the likelihood of irregular heart rhythms or arrhythmias. A high score suggests stability, while a low score indicates potential risks.

    Autonomic Integrity Score
Evaluates the overall activity and the balance between sympathetic and parasympathetic nervous system activity at the time of measurement, providing a snapshot of autonomic function.

Source: HeartReader marketing

Quick, Non-Invasive Measurements
All these insights are derived from a simple, non-invasive, two-minute measurement. HeartReader delivers a comprehensive evaluation that goes far beyond what is typically expected from such a straightforward process, empowering both clinicians and individuals to better understand and manage cardiovascular health.

To make the data easy to interpret for both professionals and laypeople, the 30 parameters are summarized into a simplified metric called Scores. These scores not only reflect potential medical conditions but also provide valuable insights into the individual's overall health level.

Based on a database of 150,000 measurements, we developed the HeartReader Health Map™, which benchmarks health levels for individuals aged 15 to 85. This map assigns a health score on an absolute scale from 0 to 100, where higher numbers indicate better health. Additionally, it uses a relative scale, which compares an individual's health to others in the same age group, similar to percentile rankings in other medical assessments.

This dual-scale approach offers professionals a powerful diagnostic tool while also serving as an accessible screening resource for non-experts, providing a comprehensive understanding of an individual's health status.

Our long-term vision is to integrate HeartReader into medical practice as a prescription-based service. General practitioners, cardiologists, rehabilitation specialists, and obstetricians can invite their patients to use this advanced physiological monitoring and data collection system.


Study 1: Pulse Wave Morphology Analysis
The first study focused on the repeatability and accuracy of pulse morphology analysis. Our primary goal was to determine whether variations in measurements were due to device inaccuracy or the inherent dynamism of human physiology. To address this, we conducted tests using a pulse wave generator, a device that produces a consistent pulse wave regardless of timing or settings.

Results demonstrated that when the HeartReader receives the same input signal, its output remains consistent, proving the system’s high level of accuracy in capturing and analyzing data.

Source: HeartReader marketing












Source: HeartReader marketing

Study 2: Heart Rate Variability (HRV) and Pulse Rate Variability (PRV) Analysis
The second publication examined the system's capability in heart rate variability (HRV) analysis, comparing it to the gold-standard software, KubiosQBS, widely used for HRV research.

     When the same input data was analyzed by both KubiosQBS and HeartReader, the results showed a 99% agreement, affirming that HeartReader's HRV engine is as accurate as (or potentially even slightly more accurate than) KubiosQBS.

     Additionally, we compared ECG-based HRV with HeartReader's peripheral pulse-based pulse rate variability (PRV). The correlation between the two methods aligned closely with existing medical literature, further validating the system's precision and applicability.


Key Findings
These studies confirm that:

  1. Pulse Morphology Analysis is highly accurate and repeatable, reliably capturing physiological signals for preclinical use.
  2. HRV and PRV Analysis delivers results comparable to established gold-standard systems, making HeartReader a robust tool for understanding cardiovascular and autonomic nervous system dynamics.

HeartReader is proven to offer accurate readings in Pulse Morphology, HRV and PRV Analysis.  It works ideally for the support of function/ personalized health monitoring and clinical support. This validation sets the stage for its successful integration into medical practice.


Evaluating System Performance in Clinical Contexts
The next critical question is: How does the HeartReader system perform under specific clinical conditions? While there is no universally accepted gold standard for peripheral pulse wave monitoring, our extensive dataset offers compelling insights into its reliability and clinical relevance.


Large-Scale Data Validation
With over 150,000 measurements collected from more than 8,000 individuals aged 15 to 85, our analysis revealed a strong correlation between many of the 30 calculated parameters and age. Since physiological and hemodynamic functions naturally evolve with age, this alignment with well-documented aging patterns serves as a robust internal validation of the system. The fact that HeartReader accurately reflects these age-related changes, recognized as "normal" by cardiologists and the broader medical community, reinforces the system’s credibility and precision.

Highlighting Individual Variability
In addition to reflecting typical aging trends, HeartReader uncovers individual differences in aging rates and cardiovascular health. Some individuals demonstrate faster or slower aging patterns, with corresponding variations in cardiovascular risks and conditions. This variability underscores the system's ability to go beyond averages and offer personalized insights. By identifying where a person falls relative to their age group, HeartReader provides a detailed picture of individual cardiovascular health, making it a powerful tool for early detection and intervention.

Establishing Age-Based Averages
Despite individual differences, the extensive data pool has enabled us to establish clear averages for each age group. These benchmarks further validate the system's capacity to serve as a precise and personalized monitoring tool, offering healthcare providers a reliable means of assessing cardiovascular health and guiding patient care.

HeartReader's combination of large-scale validation, individual variability analysis, and alignment with established medical norms positions it as a cutting-edge system for clinical and personalized health applications.

 

About the Author/Developer:

Dr. Sándor Kulin graduated as a medical doctor in 1990 at Semmelweis University, Budapest, and became an obstetrician and gynecologist at Imre Haynal University of Health Sciences in 1994.   He has special interest in maternal and fetal health, human physiology, cell physiology, hypoxia, malignant transformation, and therapy monitoring. Having almost 20 years of experience in non-invasive cardiovascular monitoring in 2018 he became a Co-founder and CEO of E-Med4All Europe Ltd, a Hungarian digital health startup, aiming to help the transformation towards a more data driven and personalized medicine and to be part of the shift of today’s medicine from disease management to prevention.



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