Often times there are no visible symptoms to determine if a patient has suffered from trauma. A heart rate complexity metric developed by Vicor Technologies (Boca Raton, Florida) called PD2i is doing just that.
The company most recently reported that the U.S. Army Institute of Surgical Research (USAISR) has identified its PD2i as a heart rate complexity matrix that will be tested on trauma patients under the new Critical Combat Care Engineering program. Vicor's PD2i Cardiac Analyzer risk stratifies patients who are at high or low risk of suffering a fatal arrhythmic event or sudden cardiac death (SCD) within a six-month time frame.
But the technology can be adapted to analyze any biological stream of data. The proprietary point correlation dimension algorithm (PD2i) is a deterministic, non-linear measure that analyzes electrophysiological potentials to predict future pathological events with a high degree of accuracy in target populations.
It also is in clinical trials for 510(k) clearance for use of the algorithm in 1) risk stratifying of combat and civilian trauma victims (PD2i VS) and 2) identifying patients at risk of suffering sudden cardiac death (PD2i CA).
Vicor entered into an agreement with USAISR over the diagnostics metric back in January 2008. The goal is that the metric would be able to determine the severity of injury and probability of survival in critically injured soldiers and civilian patients using both raw and noisy EKG data.
"Our metric was able to outperform the others and tell which patients were seriously injured and were not." Daniel Weiss, MD, told Medical Device Daily. "It's a metric that looks at the variation of the heart rate and we look at the pattern. From there we determine is this a pattern that looks at it as if the brain is ok or in trouble."
The identification of the PD2i as a heart-rate complexity metric to be tested on trauma patients in C3E was recently featured in "Bridging the Critical Care Chasm," an article describing the C3E. C3E is a new program area within the U.S. Army Medical Research and Materiel Command's Combat Casualty Care Research Area Directorate (RAD II) that was created to improve battlefield care and, specifically, address the "critical care technology gap." The article appears in the August 2009 issue of Military Medical/CBRN Technology.
To date Vicor has been making tremendous headway with PD2i and the metric which was developed in the 90s has been featured in a host of publications. Just Last May Vicor reported that the journal Therapeutics and Clinical Risk Management had accepted for publication in its August issue positive results of a clinical study conducted by the company titled "Risk stratification for arrhythmic death in an emergency department cohort: a new method of nonlinear PD2i analysis of the ECG (MDD, June 27, 2008).
The study enrolled 918 patients – 876 of whom completed the study – in six emergency departments. The study achieved a sensitivity of 96% and a specificity of 85% with a negative predictive value of 99%, for the PD2i.
The Vicor product's closest competitor is Cambridge Heart's (Bedford, Massachusetts) HearTwave II Microvolt T-Wave Alternans test, which measures a specific and extremely subtle pattern of beat-to-beat fluctuations in a person's electrocardiogram.
The company said in a past interview with MDD that the primary difference between the two technologies is that Vicor will offer it as a service ($100 per patient analysis), rather than as a standalone product that physicians must purchase and keep in their offices (MDD, February 8, 2008).
Omar Ford, 404-262-5546;