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FAQs
Q: Why is heart failure a critical medical issue?
Q: Why is heart failure difficult to diagnose?
Q: How do diseases like heart failure cause the heart to produce abnormal sound?
Q: What is the clinical relevance of the third heart sound in heart failure?
Q: How can AUDICOR® help the medical system improve the clinical management and costs of heart failure?
Q: Is AUDICOR® expensive technology to buy?
Q: What is AUDICOR®?
Q: What is the technology behind AUDICOR®?
Q: How can AUDICOR® help emergency physicians diagnose heart failure?
Q: How can AUDICOR® help EMS providers diagnose heart failure?
Q: How can AUDICOR® help hospitals better manage higher risk cardiac patients including those with heart failure and acute coronary syndrome?
Q: Are there peer-reviewed publications on this technology?
Q: What clinical studies have been conducted on AUDICOR®?
Q: What clinical studies have been conducted and presented on AUDICOR® in the pre-hospital environment?
Q: What articles have been written about AUDICOR® in the pre-hospital environment?
Q: Why offer two different AUDICOR® models in the United States?
Q: How is AUDICOR® available outside the United States?
Q: What role should we expect your company to play in shaping the future of this market?
Q: Why is heart failure a critical medical issue?
Heart failure is a growing epidemic in the United States. According to the 2004 American Heart Association Heart Disease and Stroke Statistics Update, an estimated 5 million Americans have heart failure and 550,000 new cases are reported each year, total mortality of 260,000. There are approximately 1 million hospital discharges with a primary diagnosis of heart failure an additional 2.4-2.6 million discharges with heart failure as either a primary or secondary diagnosis. Further estimates suggest that heart failure is a primary complaint responsible for 12-15 million physician office visits each year. All this activity translates into a potential cost of $28.8 billion for the US healthcare system.
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Q: Why is heart failure difficult to diagnose?
Heart failure patients frequently represent diagnostic challenges to physicians because shortness of breath, a key symptom of heart failure, may be a non-specific finding in many elderly or obese patients. Clinicians need to differentiate patients with heart failure from other diseases, such as pulmonary disease. A patient’s past history is helpful, but only 81% accurate; chest x-rays are also helpful, but only 75% accurate. Lab tests are good tools; however, studies indicate results are negatively influenced by a variety of diseases. AUDICOR® identifies the third heart sound, which studies confirm is a highly specific marker for heart dysfunction associated with heart failure.
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Q: How do diseases like heart failure cause the heart to produce abnormal sound?
The heart produces both normal (“lub-dub”) and abnormal sounds as blood moves throughout the heart. Cardiac diseases including heart failure cause the heart muscle to stiffen, making it difficult for the heart to properly contract and relax as it pumps blood. The abnormal third heart sound is produced when fast moving blood is suddenly stopped because the stiffened heart wall is unable to stretch.
Click here to visit Learn About Heart Sounds page to learn more.
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Q: What is the clinical relevance of the third heart sound in heart failure?
The presence of a third heart sound has high prognostic and diagnostic value in adults over 40 years old who exhibit signs and symptoms associated with heart failure. A landmark study published in the New England Journal of Medicine indicated the presence of a third heart sound (S3) is 99% specific for heart failure and leads to increased morbidity and mortality. The absence of a third heart sound, however, it is not sufficient to exclude ventricular dysfunction, so further diagnostic investigations should be considered.
Click here to visit Learn About Heart Sounds page to learn more.
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Q: How can AUDICOR® help the medical system improve the clinical management and costs of heart failure?
AUDICOR® is a low cost non-invasive, technology that can be performed at the point-of-care in the pre-hospital environment, emergency departments, hospital inpatients, and physicians’ offices by varying levels of skilled technicians because of its easy-to-use interface. It provides clinically important and actionable information about the heart’s hemodynamic properties previously obtained by more expensive technologies, including echocardiography. The result is more heart failure patients may have access to better care because their care providers are identifying their diseases earlier with greater accuracy. Studies indicate faster, more accurate diagnosis enables earlier treatment, decreased mortality, decreased complications, and decreased cost.
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Q: Is AUDICOR® expensive technology to buy?
No. Because AUDICOR® is low cost, it does not require large capital expenditures for hospital or emergency medical systems to adopt this new innovative technology and begin realizing economic gains in several areas of the hospital (Emergency Department and Inpatient). AUDICOR® products are designed both as an add-on to existing cardiovascular equipment or as a stand alone unit, making it easy to incorporate into standard care protocols and workflows.
Click here to visit Economics page to learn more.
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Q: What is AUDICOR®?
AUDICOR® is the first non-invasive technology to accurately diagnose, quickly assess, and easily monitor higher risk cardiac conditions including heart failure and acute coronary syndrome (ACS). AUDICOR® is delivering value across the continuum of care because of its cost-effective nature and actionable diagnostic results that are helping improve missed diagnosis rates, facilitating earlier treatments, and improving clinical outcomes of patients.
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Q: What is the technology behind AUDICOR®?
AUDICORŪ uses a patented signal processing technology called acoustic
cardiography to simultaneously integrate heart sounds and
single-channel electrocardiography input
to generate multiple parameters that correlate to established
hemodynamic measures. Dual-function AUDICOR sensors are placed on a
patient’s chest to record the incoming signals.
Click here to visit Our Technology page to learn more.
Click here to visit Our Technology page to learn more.
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Q: How can AUDICOR® help emergency physicians diagnose heart failure?
Eighty percent of heart failure admissions are diagnosed in the emergency departments, where the misdiagnosis rate for primary heart failure is between 10-20%. In one study, AUDICOR® helped correct approximately 34% of the missed diagnosed patients. These missed patients had 3x the incidence of pulmonary disease, less history of heart failure, and lab BNP results under the 500 pg/ml cut-off, and longer lengths of hospital stays. AUDICOR® is helping reduce the missed diagnosis rate and shorten lengths of hospital stays by providing actionable diagnostic data at the patient’s bedside.
Click here to visit Audicor CE page to learn more.
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Q: How can AUDICOR® help EMS providers diagnose heart failure?
Currently, EMS providers use patient history and physical exams to diagnose a patient’s shortness of breath. However, patient history is often not available and physical examination is often non-specific. A pre-hospital study of 222 adult patients with shortness of breath noted an overall diagnosis error of 23%. In those patients with co-morbidities, e.g. chronic obstructive pulmonary disease (COPD), heart failure was missed in 46%. Accurate pre-hospital diagnosis and treatment improves patient outcomes. Conversely, administrating heart failure drugs to patients with non-cardiac shortness of breath increases patient mortality (13.6% improper treatment vs. 3.8% proper treatment). AUDICOR® identifies the third heart sound, which in the appropriate clinical context should lead EMS providers to consider heart failure as a potential diagnosis.
Click here to visit Audicor 200D page to learn more.
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Q: How can AUDICOR® help hospitals better manage higher risk cardiac patients including those with heart failure and acute coronary syndrome?
Many higher risk patients arrive to hospitals via emergency medical systems. An accurate diagnosis in the pre-hospital environment may help EMS providers direct patients to medical centers with facilities designed for cardiac care, helping hospitals better manage their increasing overcrowded emergency departments. Many hospitals are benefiting from AUDICOR® in their facilities through reductions in under or missed diagnoses, earlier initiation of treatment, shorter lengths of hospital stays, and improvements on their core measure performance, which is tracked by the Center for Medicare Services (CMS) and Joint Commission on Accreditation of Healthcare Organizations (JCAHO). These core measures are a hospital’s quality scorecard and new federal laws will begin impacting the economics of the hospital based on their performance. Studies indicate AUDICOR® used upfront in the earliest part of the emergency department evaluation can help eliminate missed diagnoses and assist the heart failure team to undertake the key core measure activities.
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Q: Are there peer-reviewed publications on this technology?
Yes. Several clinical papers have been published in leading scientific medical journals authored by experts in heart failure care including the Journal of the American Medical Association, Congestive Heart Failure, American Journal of Emergency Medicine, and the Archives of Internal Medicine. Through these peer-reviewed publications, physicians are learning the clinical utility of AUDICOR® technology and helping them improve how they clinically manage heart failure patients.
Click here to visit Publications page to learn more.
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Q: What clinical studies have been conducted on AUDICOR®?
Since first being introduced in 2003, several clinical studies have been conducted investigating AUDICOR® technology. Topics of interest include the prevalence of abnormal heart sounds, the role of heart sounds in the pre-hospital environment, the diagnostic and prognostic usefulness of heart sounds in heart failure and acute coronary syndrome, the effects of pharmacologic treatment on the presence or absence of the third heart sound, and the monitoring of cardiac function resulting from changes in synchronization therapy. The results of these studies have been presented at premier medical and scientific sessions and conferences including the American College of Cardiology, the Society of Emergency Medicine, The Heart Failure Society of America, and other medical/engineering conferences. The current multi-center study is called HEart failure and Audicor Technology for Rapid Diagnosis and Initial Treatment (HEARD-IT) Trial.
Click here to visit Clinical Trials and Events pages to learn more.
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Q: What clinical studies have been conducted and presented on AUDICOR® in the pre-hospital environment?
Since first being cleared by the FDA in 2003 for commercial release, several clinical studies have been conducted investigating AUDICOR® technology. Topics of interest include the use of heart sounds in the pre-hospital diagnosis of heart failure and acute coronary syndrome. These experiences have been presented in lectures at premier conferences including ClinCon.
Click here to visit Events page to learn more.
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Q: What articles have been written about AUDICOR® in the pre-hospital environment?
Several articles have been written in both Journal of Emergency Medicine (JEMS) and Emergency Medical Systems (EMS). AUDICOR® 200D was selected as a Top New Product at EMS Expo 2005 and featured as a FANTASTIC FIND in the EMS 2005 Buyers Guide.
Click here to visit Articles page to learn more.
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Q: Why offer
three different AUDICOR® models in the United States?
Each model is designed to seamlessly fit into different clinical environments and existing workflows.
AUDICORŪ TS is the first portable acoustic cardiograph for the
rapid, non-invasive measurement of hemodynamic function in the
hospital or clinic setting. AUDICOR® CE is a small add-on device to existing electrocardiographs (ECG) already being used in hospitals and clinics. This product allows medical institutions to quickly incorporate AUDICOR® technology into their facilities without large capital expenditures. AUDICOR® 200 is lightweight and portable all-in-one device, and is currently being used in the pre-hospital community by Emergency Medical Systems, where the availability of cardiac diagnostic tools is very limited.
Click here to visit Products page to learn more.
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Q: How is AUDICOR® available outside the United States?
Currently, Inovise Medical has partnership agreements in place with leading cardiovascular equipment companies in Japan and China to embed our technology.
Click here to visit Partners page to learn more.
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Q: What role should we expect your company to play in shaping the future of this market?
Our vision for AUDICOR® is for it to be used routinely as an evaluator of cardiac function making it the standard of care for non-invasive, actionable cardiac assessment worldwide. Inovise Medical, the developer of AUDICOR®, is the pioneer and leader in simultaneous digital heart sound and electrocardiography technology that is shaping non-invasive cardiac care worldwide. Our international team of experts in the areas of diagnostic cardiology, patient monitoring, biomedical engineering and healthcare marketing/sales work collaboratively with globally-respected medical luminaries and corporate leaders to lead the delivery of new, innovative diagnostic tools that deliver both clinical and economic value. AUDICOR® will become the vital sign for the heart with value and applications that span across the continuum of care.
Click here to visit Inovise Medical Corporate page to learn more.
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References:
American Heart Association. Heart and Stroke Statistical Update. 2005.
Bebout ED. Summary Report. 2003. Inovise Medical, Inc.
Roos M, Toggweler S, Zuber M,
Jamshidi P, Erne P. Acoustic cardiographic
parameters and their relationship to invasive hemodynamic measurements
in
patients with LV systolic dysfunction. Congestive Heart Failure.
2006;12(4
suppl 1):19-24.
Collins SP, Lindsell CJ, Storrow AB, Abraham WT. Prevalence of negative chest radiography results in the emergency department patient with decompensated heart failure. Ann Emerg Med. In press.
Collins SP, Lindsell CJ, Peacock WF, Hedger VD, Storrow AB. The effect of treatment on the presence of abnormal heart sounds in emergency department patients with heart failure. Am J of Emerg Med. 2006;24:25-32.
Dao Q, Krishnaswamy P, Kazanegra R, Harrison A, Amirnovin R, Lenert L, et al. Utility of B-type natruretic peptide in the diagnosis of congestive heart failure in an urgent care setting. J Am Coll Cardiol. 2001;37(2):379-385.
Drazner MH, Rame JE, Phil M, Stevenson LW, Dries DL. Prognostic importance of elevated jugular venous pressure and a third heart sound in patients with heart failure. N Engl J Med. 2001;345(8):574-581.
Marcus GM, Gerber IL, McKeown BH, Vessey JC, Jordan MV, Huddleston M, et al. Association between phonocardiographic third and fourth heart sounds and objective measures of left ventricular function. JAMA. 2005;293(18):2238-2244.
McCullough PA, Nowak RM, McCord J, et al, for the BNP Multi-national Study Investigators. B-type naturetic peptide and clinical judgement in emergency diagnosis of heart failure. Analysis from Breathing Not Properly (BNP) multi-national study. Circulation. 2002;106:416-422.
Peacock WF, Emerman CL, Costanzo MR, Borkowitz RL, Cheng M. Early initiation of intravenous therapy improve heart failure outcomes: An analysis from the ADHERE registry database. Ann of Emerg Med. 2003;42(4),S26.
Pozner CN, Levine BS, Shapiro N, Hanrahan JP, et al. Concordance of field and emergency department assessment in the pre-hospital management of patients with dyspnea. Prehospital Emerg Care. December 2003:440-444.
Wuerz RC, Meador, SA. Effects of prehospital medications on mortality and length of stay in congestive heart failure. Ann of Emerg Med. 1992;21:669-674.
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