Papers

Therapeutics & Clinical Risk Management
August 2009

“Comparison of linear-stochastic and nonlinear-deterministic algorithms in the analysis of 15-minute clinical ECGs to predict risk of arrhythmic death”

This paper documents the comparative evaluation of nonlinear algorithms and conventional linear-stochastic measures of heartbeat series in low- to high-risk cardiac patients to prospectively predict risk of arrhythmic (sudden cardiac) death. Vicor’s time-dependent PD2i® nonlinear algorithm was demonstrated to be the comparatively superior test.

Therapeutics and Clinical Risk Management
August 2008

“Risk stratification for arrhythmic death in an emergency department cohort:  a new method of nonlinear PD2i® analysis of the ECG”

This paper describes a study in which the PD2i® nonlinear algorithm was used to analyze heart rate variability in 918 patients admitted to six emergency departments for chest pain and determination of risk of acute myocardial infarction.  Vicor’s PD2i® nonlinear algorithm demonstrated the ability to predict risk of arrhythmic death with a sensitivity of 96 percent and a specificity of 85 percent, with a negative predictive value of 99 percent.

Journal of Critical Care
June 2008

“Exploration of heart-rate complexity to determine the need for lifesaving intervention in combat casualties”

This paper describes Vicor’s first collaborative effort with the USAISR in which ECGs from 11 combat casualties were analyzed off-line using nonlinear methods to assess the feasibility of heart rate complexity (HRC) analysis to provide a new “vital sign” capable of determining the need for lifesaving intervention in the theater.  The PD2i® nonlinear algorithm, one of three nonlinear methods analyzed, was the only method that correctly identified the need for lifesaving intervention in all cases, suggesting the potential utility of HRC measurement as a tool for identifying the need for lifesaving intervention in combat casualties in the theater.

Vicor’s collaboration with the USAISR is continuing.  Results of additional studies will be submitted to appropriate publications when complete.

Therapeutics and Clinical Risk Management
April 2008

“Nonlinear Analysis of the Heartbeats in Public Patient ECGs Using an Automated PD2i Algorithm for Risk Stratification of Arrhythmic Death”

The paper describes a study in which 397 emergency room patients presenting with chest pain were evaluated by seven methodologies: the PD2i® nonlinear algorithm, DFA, ApEn, SDNN, MNN, 1/f-Slope, and LF/HF. The study demonstrated that the PD2i® nonlinear algorithm, based on a deterministic model, provided superior assessment of heart rate variability in brief ECGs, as compared with measures based on linear stochastic and nonlinear models, thus providing the basis for a rapid, accurate, and cost-effective stratification of risk of arrhythmic death in patients presenting in an emergency department.


Presentations

2010 Heart-Brain Summit
September 2010

James E. Skinner, MD, Vicor’s Vice President and Director of Grant Research, presented abstracts of three studies involving  the PD2i® nonlinear algorithm — “Short-Term Heart Rate Complexity Determined by the PD2i® Algorithm is Reduced in Patients with Type 1 Diabetes Melitus,” “Prognostic Significance of PD2i® in Heart Failure Patients,”  and “Mild Hypovolemia and PD2i®” – at the 2010 Heart-Brain Summit at the Cleveland Clinic Lou Ruvo Center for Brain Health.

The Heart-Brain Summit, now in its fifth year, is the annual event of The Society for Heart Brain Medicine. The Society for Heart-Brain Medicine provides a forum for researchers and clinicians from different disciplines, both clinical and laboratory, to present, discuss, and evaluate data, and promotes the study of heart-brain medicine as a discipline in its own right.

AABB 2010 Annual Meeting
October 2010

Daniel Weiss, MD, Vicor’s Chief Medical Officer, presented an abstract of the results of a pilot study to test the ability of Vicor’s PD2i® nonlinear algorithm to detect acute hypovolemia – “Mild Hemorrhage Results in Observable Changes in Heart Rate Variability” at the AABB 2010 Annual Meeting.

The study on which the abstract is based was conducted in cooperation with the University of Mississippi Medical Center and Mississippi Blood Services on December 12, 2009 in Smithdale, MS.  The goal of the study was to test the ability of Vicor’s PD2i® nonlinear algorithm to identify acute hypovolemia in blood donors as a preliminary step toward ascertaining whether it could be a useful noninvasive diagnostic for detecting blood loss from internal bleeding.  All 18 participants in the pilot study were tested prior to donation to determine a baseline PD2i® value, and re-tested during and after collection.  The average PD2i® value of participants prior to donation was 2.60; the average PD2i® value following donation was 1.80. With a P value of 0.001, the study results are highly statistically significant; this indicates a better than 99% probability that the results were not achieved randomly.

The AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies.  The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety.  AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. Members are located in more than 80 countries.

American Heart Association -
Resuscitation Science Symposium 2009
November 2009

Andriy Batchinsky, MD, a researcher with the USAISR, discussed Vicor’s proprietary PD2i® nonlinear algorithm in his presentation — “Does Heart-Rate Complexity Analysis Work in the Real World?  Changes in the Point Correlation Dimension of Heart Rate During Prehospital Lifesaving Interventions”  – at the American Heart Association’s Resuscitation Science Symposium 2009

The American Heart Association’s Resuscitation Science Symposium (ReSS) is an international forum for fundamental, translational, clinical and population scientists and care providers to discuss recent advances related to treating cardiopulmonary arrest and life-threatening traumatic injury.

Smart Monitoring 2009/ATACCC 2009 Conference
August 2009

Dr. Batchinsky identified Vicor’s PD2i VS™ as a new vital sign diagnostic that more accurately risk stratifies trauma severity and the probability of survival in the critically injured during presentations at  Smart Monitoring 2009 and the Advanced Technology Applications for Combat Casualty Care (ATACCC) 2009 Conference.

Both Dr. Batchinsky’s presentations provided a review of findings from studies completed under Vicor’s ongoing collaborative research agreement. “Toward Automated Detection of Life-Threatening Injury Using Comprehensive Assessment of the Electrocardiogram” was presented at the Smart Monitoring 2009 forum during the New Vital Signs, Predictive Variables and Indices panel.  “Does Heart Rate Complexity Add to Traditional Vital Signs for Trauma Patient Triage?” was presented at the ATACCC 2009 Conference.

Sponsored by the Resuscitation Research Laboratory of the University of Texas Medical Branch, Smart Monitoring addresses the need for new technologies requiring innovation from government, academia, and industry by providing a forum for communication between industry representatives and expert medical caregivers.  The premier scientific meeting of the Department of Defense, ATACCC addresses advances in trauma medicine and the unique medical needs of the war fighter, with a focus on identifying technologies that can meet increasingly complex operational issues.

8th International Conference on
Complexity in Acute Illness

August 2009

Dr. Batchinsky presented “Are We Listening to Music or Noise? Use of the Lyapunov Exponent for Comprehensive Assessment of Heart Rate Complexity during Hemorrhage in Sedated Conscious Miniature Swine.”

International Experts of
Complexity and Variability at the Bedside
Round Table
August 2009

“Complexity in Animal Models” and “Continuous Complexity Analysis and Remote Battlefield Triage” were presented by Dr. Batchinsky.

ATACCC 2008 Conference
June 2008

“Prediction of Injury Severity and Outcome in the Critically Ill Using the Point Correlation Dimension Algorithm” focused on findings from studies of the PD2i® nonlinear algorithm completed under its collaborative research agreement with Vicor.

6th Congress of
the International Federation of Shock Societies
&
31st Annual Conference on Shock
June 2008

Dr. Batchinsky presented findings from studies of the PD2i® nonlinear algorithm completed under its collaborative research agreement with Vicor in “Exploration of Heart-Rate Complexity to Determine the Need for Lifesaving Intervention in Combat Casualties.”