Cardiology Researcher Dr. Wojciech Zareba Addresses Need to Improve Risk Stratification of Heart Failure Patients Eligible for ICD or CRT-D

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A recent study reveals that 40% of heart failure patients who receive CRT-ICD therapy do not benefit from the device. Dr. Wojciech Zareba suggests additional diagnostics are needed to determine who will benefit prior to incurring the high risk and cost associated with implantation.

Wojciech Zareba, MD, PhD

We need to more accurately identify those patients who will benefit from interventions that can reduce the enormous expenditures associated with heart failure decompensation.

Responding to a recent study showing that 40% of patients who receive CRT-ICD therapy do not benefit from the device (Sipahi, et al – 6/13/11), Wojciech Zareba, MD, PhD, stated that improving risk stratification of heart failure patients eligible for an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy with a defibrillator (CRT-D) is essential. He notes that patients with left bundle branch block QRS morphology derived the most benefit from CRT-D, however, additional methods are needed to further ensure benefit of this therapy.

Dr. Zareba is Professor of Medicine, Director of Cardiology Clinical Research, and Director of the Heart Research Follow-up Program at the University of Rochester Medical Center. He was the Principal Investigator on a study conducted under a collaborative agreement between Vicor Technologies, and the University of Rochester and the Catalan Institute of Cardiovascular Sciences in Barcelona. Vicor Technologies is a biotechnology company focused on the commercialization of its PD2i Analyzer™, an innovative, non-invasive diagnostic employing its patented, proprietary PD2i® nonlinear algorithm. Physician use of the PD2i Analyzer™ is supported by an expanding body of literature documenting the PD2i® nonlinear algorithm as a metric for risk stratifying specific target populations for future pathological events, including diabetics for the presence of diabetic autonomic neuropathy (DAN), cardiovascular disease patients for death resulting from arrhythmia or congestive heart failure, and trauma victims for imminent death absent immediate lifesaving intervention.

Dr. Zareba is a world-renowned cardiac researcher. He serves as Principal Investigator of ECG Core Labs’ studies, including the International LQTS Registry, the North American ARVD Registry, MADIT II, and MADIT-CRT, and large clinical trials testing the clinical effectiveness and safety of implantable cardiac defibrillators and resynchronization devices. Additionally, he served as Principal Investigator or co-Principal Investigator on numerous NIH- and corporate-funded studies focused on risk stratification of cardiac death and, clinical usefulness and prognostic significance of ECG parameters.

“Given the overburdened state of our health system, we cannot afford to have patients receive expensive therapies like ICDs and CRT-Ds that are not beneficial. Specifically, we need to more accurately identify those patients – specifically those at highest risk for cardiac and heart failure morbidity and mortality -- who will benefit from interventions that can reduce the enormous expenditures associated with heart failure decompensation, most significantly hospital/ICU admissions. Early intervention targeting those at highest risk for future decompensation may well help avoid costly re-admissions later,” Dr. Zareba stated.

To underscore the magnitude of the problem and its impact on the U.S. healthcare system, Dr. Zareba referenced the following statistics

  •     According to the American Heart Association, heart failure affects nearly 5.7 million Americans of all ages and is responsible for more hospitalizations than all forms of cancer combined. It is the leading cause for hospitalization among Medicare patients.
  •     Heart failure is the fastest-growing clinical cardiac disease entity in the U.S., affecting 2% of the population.
  •     Each year, 550,000 new cases of heart failure are diagnosed and 300,000 deaths are caused by heart failure.
  •     Nearly 2% of all hospital admissions in the U.S. are for decompensated heart failure; heart failure is the most frequent cause of hospitalization in patients older than 65 years, with an annual incidence of 10 per 1,000.
  •     The average duration of hospitalization for heart failure is 6 days.

Dr. Zareba explained that heart failure patients typically experience an insidious downward spiral. Their heart and overall physiology -- cardiac shape and function, and neurohormonal balance -- undergo “negative remodeling” resulting in more severe heart failure and eventually death. Initially, despite these negative changes having already begun, heart failure patients may appear relatively stable.

“Being able to identify those heart failure patients entering the downward spiral, especially in the early stages when interventions may be far more likely to succeed – be they lifestyle/nutrition, pharmacological, or device/procedural – has the potential to result in improved quality of life and vast cost savings for our overburdened healthcare system. The results of ‘Prognostic Significance of Point Correlation Dimension Algorithm (PD2i) in Chronic Heart Failure’ are of major importance for those involved in the search to identify a means of enhancing risk stratification of heart failure patients eligible for ICD or CRT-D, ” Dr. Zareba continued.

The goal of “Prognostic Significance of Point Correlation Dimension Algorithm (PD2i) in Chronic Heart Failure” was to evaluate the ability of Vicor’s PD2i® nonlinear algorithm, to predict cardiac events in the 537 chronic heart failure patients enrolled in the MUSIC Trial; MUSIC Trial participants were followed for an average period of 44 months. The conclusion of the University of Rochester researchers who conducted the study is that the PD2i® nonlinear algorithm and software is predictive of total mortality, cardiac death, and heart failure death in patients with left ventricular ejection fraction of less than or equal to 35%. With a hazard ratio of 2.34 and a P value of 0.023 for congestive heart failure mortality, a hazard ratio of 1.89 and a p value of .013 for cardiac mortality and a hazard ration of 1.95 and a p value of .004 for total mortality, the study results are highly statistically significant and demonstrated the ability of the PD2i Analyzer™ to identify those patients at an elevated risk of total mortality, cardiac mortality and congestive heart failure death.

The results of this study appeared in a poster presentation -- "Prognostic Significance of PD2i, Novel Risk Marker in Heart Failure Patients” – at the American College of Cardiology 60th Annual Scientific Session on April 4, 2011

“These results are of major importance for risk stratifying heart failure patients who are eligible for therapy with an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy with defibrillator (CRT-D). Testing heart failure patients using the PD2i® should enhance risk stratification and motivate physicians to implant these devices in ICD/CRT-D eligible patients with abnormal PD2i® test results,” Dr. Zareba concluded.

The appearance of name-brand institutions, such as the Heart Research Follow-up Program at the University of Rochester Medical Center, the University of Rochester, the Catalan Institute of Cardiovascular Sciences ECG Core Labs, and NIH, in this media release does not constitute endorsement by institutions of the information, products or services contained therein.

Caution Regarding Forward-Looking Statements
Forward-looking statements in this press release are based on current plans and expectations that are subject to uncertainties and risks, which could cause our future results to differ materially. The following factors, among others, could cause our actual results to differ: our ability to successfully complete the normal range study for PD2i® values; our ability to generate revenues from the sale of the PD2i Analyzer™; our ability to obtain the necessary regulatory approvals to market the PD2i Analyzer™; our ability to develop additional applications for the PD2i Analyzer™; the ability of additional sales representatives to create revenue; our ability to continue to receive financing sufficient to continue operations and complete critical clinical trials; our ability to continue as a going concern; our ability to successfully develop products based on our technologies; our ability to obtain and maintain adequate levels of third-party reimbursement for our products; the impact of competitive products and pricing; our ability to receive regulatory approval for our products; the ability of third-party contract research organizations to perform preclinical testing and clinical trials for our technologies; the ability of third-party manufacturers to manufacture our products; our ability to retain the services of our key personnel; our ability to market and sell our products successfully; our ability to protect our intellectual property; product liability; changes in federal income tax laws and regulations; general market conditions in the medical device and pharmaceutical industries; and other matters that are described in Vicor's Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and subsequent filings with the Securities and Exchange Commission. Forward-looking statements in this press release speak only as of the date of the press release, and we assume no obligation to update forward-looking statements or the reasons why actual results could differ.

Release 11-17


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